Fed. Reg. Rules and Regulations — Final amendment; fi…

BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 [Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610] Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations.

FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.

DATES: This order is effective December 30, 2019. FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5502, Silver Spring, MD 20993, 301-796-9603, email: *karen.fikes@fda.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Background The Cures Act (Pub. L. 114-255) was signed into law on December 13, 2016. Under the Cures Act, section 3054 amended section 510(l) and

(m)of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360(l) and (m)). As amended, section 510(l)(2) of the FD&C Act requires FDA to identify through publication in the **Federal Register** , any type of class I device that the Agency determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. FDA shall publish this determination within 120 days of the date of enactment of the Cures Act and at least once every 5 years thereafter, as FDA determines appropriate. Further, section 510(l)(2) provides that upon the date of publication of the Agency's determination in the **Federal Register** , a 510(k) will no longer be required for these devices and the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. As amended, section 510(m)(1)(A) of the FD&C Act provides that, within 90 days after enactment of the Cures Act and at least once every 5 years thereafter, FDA shall publish in the **Federal Register** a notice containing a list of each type of class II device that FDA determines no longer requires a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. This notice shall provide at least a 60-day comment period. Within 210 days of enactment of the Cures Act, FDA shall publish in the **Federal Register** a list representing its final determination regarding exemption of devices that were contained in the proposed list published under 510(m)(1)(A) of the FD&C Act. Further, section 510(m)(3) of the FD&C Act provides that upon the date of publication of the final list in the **Federal Register** , a 510(k) will no longer be required for these devices and the classification regulation applicable to each such device shall be deemed amended to incorporate such exemption. In the **Federal Register** of April 13, 2017 (82 FR 17841), in accordance with the amendments to 510(l)(2), FDA issued a notice of final determination to exempt a list of class I devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. In the **Federal Register** of March 14, 2017 (82 FR 13609), in accordance with the amendments to 510(m)(1)(A), FDA issued a notice proposing to exempt a list of class II devices from premarket notification requirements under section 510(k) of the FD&C Act, subject to certain limitations. After a 60-day comment period, in the **Federal Register** of July 11, 2017 (82 FR 31976), FDA issued a notice of final determination to exempt class II devices provided in the proposed list. Through this action, FDA is now amending the codified language for each listed classification regulation to reflect final determinations for these class I and class II exemptions. 1 1 FDA notes that the “ACTION” caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's

(OFR)interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook. Following publication of the notices, FDA determined that it is unnecessary to update three classification regulations (21 CFR 872.4565, 21 CFR 878.4014, and 21 CFR 880.6320) included in the class I notice, 82 FR 17841. Five product codes corresponding to these three classification regulations (EGI and EIB (21 CFR 872.4565), OVR (21 CFR 878.4014), KZF and PEQ (21 CFR 880.6320)) were identified for exemption in 82 FR 17841; however, the corresponding classification regulations were already class I, exempt from premarket notification procedures in subpart E of part 807 (21 CFR part 807, subpart E) subject to the limitations in the corresponding “.9” regulations ( *i.e.,* 21 CFR 872.9, 21 CFR 878.9 or 21 CFR 880.9); and, therefore, no revisions to the codified are necessary. Additionally, we determined that it is unnecessary to update 21 CFR 876.5820 included in the class II notice, 82 FR 13609. The product code within this classification regulation

(FKI)was identified for exemption in 82 FR 13609. However, this device type is specifically identified within the class I paragraph of this classification regulation (21 CFR 876.5820(b)(2)) and already exempt from premarket notification procedures in subpart E of part 807 subject to the limitations in 21 CFR 876.9. Therefore, no revisions to the codified are necessary. We are also making a revision to correct a misidentified classification regulation in 82 FR 31976. The notice incorrectly listed the classification regulation 21 CFR 868.1400 “Carbon dioxide gas analyzer” as corresponding with product code LLK; however, the correct classification regulation associated with product code LLK is 21 CFR 880.5780 “Medical Support Stocking”. Therefore, 21 CFR 868.1400 remains unchanged, and 21 CFR 880.5780(a)(2) is revised to reflect the exemption. We are revising the name of one classification regulation, currently entitled “Urological clamp for males”, in response to FDA's exemption in 82 FR 17841. Part 876.5160 is currently entitled “Urological clamp for males,” which was previously exempt from premarket notification procedures “. . . Except when intended for internal use or use on females . . .”. In 82 FR 17841, we exempted product code MNG, “External Urethral Occluder, Urinary Incontinence-Control, Female” and removed the current limitation language regarding “use on females.” Therefore, FDA is revising the name of the classification regulation to read “Urological clamp” to ensure clarity. II. Criteria for Exemption As amended by the Cures Act, section 510(l) now has two provisions, 510(l)(1) and (2). Under 510(1)(1), a class I device is exempt from the premarket notification requirements under section 510(k) of the FD&C Act, unless the device is intended for a use which is of substantial importance in preventing impairment of human health or it presents a potential unreasonable risk of illness or injury. Based on these criteria, FDA evaluated all class I devices to determine which device types should be exempt from premarket notification requirements. For class II devices, there are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the January 21, 1998, **Federal Register** notice (63 FR 3142) and subsequently in the guidance we issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions From Premarket Notification, Guidance for Industry and CDRH Staff ”. 2 2 Available at: *https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff.* III. Limitations on Exemptions Although FDA exempted the types of class I and class II devices from the premarket notification requirements under section 510(k) of the FD&C Act in accordance with the provisions under 510(l) and (m), an exemption from the requirement of premarket notification does not mean the device is exempt from any other statutory or regulatory requirements, unless such exemption is explicitly provided by order or regulation. FDA's determination that premarket notification is unnecessary to provide a reasonable assurance of safety and effectiveness is based, in part, on the assurance of safety and effectiveness that other regulatory controls, such as current good manufacturing practice requirements, provide. In addition to being subject to the general limitations to the exemptions found in 21 CFR 862.9 to 892.9, FDA has also partially limited some exemptions from premarket notification requirements to specific devices within the listed device type. In such situations where a partial exemption limitation has been identified, FDA has determined that premarket notification is necessary to provide a reasonable assurance of safety and effectiveness for these devices. IV. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. V. Paperwork Reduction Act of 1995 This final order refers to previously approved FDA collections of information. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073. List of Subjects 21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and 890 Medical devices. 21 CFR Part 864 Blood, Medical devices, Packaging and Containers. 21 CFR Part 866 Biologics, Laboratories, Medical devices. 21 CFR Part 886 Medical devices, Ophthalmic goods and services. 21 CFR Part 892 Medical devices, Radiation protection, X-rays. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888, 890, and 892 are amended as follow: PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 1. The authority citation for part 862 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 2. In § 862.1020, revise paragraph

(b)to read as follows: § 862.1020 Acid phosphatase (total or prostatic) test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 3. In § 862.1090, revise paragraph

(b)to read as follows: § 862.1090 Angiotensin converting enzyme (A.C.E.) test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 4. In § 862.1100, revise paragraph

(b)to read as follows: § 862.1100 Aspartate amino transferase (AST/SGOT) test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 5. In § 862.1150, revise paragraph

(b)to read as follows: § 862.1150 Calibrator.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 6. In § 862.1345, revise paragraph

(b)to read as follows: § 862.1345 Glucose test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 7. In § 862.1350, revise paragraph

(b)introductory text to read as follows: § 862.1350 Continuous glucose monitor secondary display.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special controls for this device are: 8. In § 862.1410, revise paragraph

(b)to read as follows: § 862.1410 Iron (non-heme) test system.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 9. In § 862.1415, revise paragraph

(b)to read as follows: § 862.1415 Iron-binding capacity test system.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 10. In § 862.1445, revise paragraph

(b)to read as follows: § 862.1445 Lactate dehydrogenase isoenzymes test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 11. In § 862.1509, revise paragraph

(b)to read as follows: § 862.1509 Methylmalonic acid (nonquantitative) test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 12. In § 862.1580, revise paragraph

(b)to read as follows: § 862.1580 Phosphorous (inorganic) test system.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 13. In § 862.1660, revise paragraph

(b)to read as follows: § 862.1660 Quality control material (assayed and unassayed).

(b)*Classification.* Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 14. In § 862.1685, revise paragraph

(b)as follows: § 862.1685 Thyroxine-binding globulin test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 15. In § 862.1700, revise paragraph

(b)as follows: § 862.1700 Total thyroxine test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 16. In § 862.1775, revise paragraph

(b)to read as follows: § 862.1775 Uric acid test system.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 17. In § 862.2265, revise paragraph

(b)introductory text to read as follows: § 862.2265 High throughput genomic sequence analyzer for clinical use.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special controls for this device are: 18. In § 862.2570, revise paragraph

(b)to read as follows: § 862.2570 Instrumentation for clinical multiplex test systems.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document. 19. In § 862.3050, revise paragraph

(b)to read as follows: § 862.3050 Breath-alcohol test system.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 20. In § 862.3100, revise paragraph

(b)to read as follows: § 862.3100 Amphetamine test system.

(b)*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 21. In § 862.3150, revise paragraph

(b)to read as follows: § 862.3150 Barbiturate test system.

(b)*Classification.* Class II (special controls). A barbiturate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 22. In § 862.3170, revise paragraph

(b)to read as follows: § 862.3170 Benzodiazepine test system.

(b)*Classification.* Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 23. In § 862.3200, revise paragraph

(b)to read as follows: § 862.3200 Clinical toxicology calibrator.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 24. In § 862.3220, revise paragraph

(b)to read as follows: § 862.3220 Carbon monoxide test system.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 25. In § 862.3240, revise paragraph

(b)to read as follows: § 862.3240 Cholinesterase test system.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 26. In § 862.3250, revise paragraph

(b)to read as follows: § 862.3250 Cocaine and cocaine metabolite test system.

(b)*Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 27. In § 862.3270, revise paragraph

(b)to read as follows: § 862.3270 Codeine test system.

(b)*Classification.* Class II (special controls). A codeine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 28. In § 862.3280, revise paragraph

(b)to read as follows: § 862.3280 Clinical toxicology control material.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. 29. In § 862.3580, revise paragraph

(b)to read as follows: § 862.3580 Lysergic acid diethylamide

(LSD)test system.

(b)*Classification.* Class II (special controls). A lysergic acid diethylamide

(LSD)test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 30. In § 862.3610, revise paragraph

(b)to read as follows: § 862.3610 Methamphetamine test system.

(b)*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 31. In § 862.3620, revise paragraph

(b)to read as follows: § 862.3620 Methadone test system.

(b)*Classification.* Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 32. In § 862.3630, revise paragraph

(b)to read as follows: § 862.3630 Methaqualone test system.

(b)*Classification.* Class II (special controls). A methaqualone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 33. In § 862.3640, revise paragraph

(b)to read as follows: § 862.3640 Morphine test system.

(b)*Classification.* Class II (special controls). A morphine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 34. In § 862.3650, revise paragraph

(b)to read as follows: § 862.3650 Opiate test system.

(b)*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 35. In § 862.3700, revise paragraph

(b)to read as follows: § 862.3700 Propoxyphene test system.

(b)*Classification.* Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 36. In § 862.3870, revise paragraph

(b)to read as follows: § 862.3870 Cannabinoid test system.

(b)*Classification.* Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). 37. In § 862.3910, revise paragraph

(b)to read as follows: § 862.3910 Tricyclic antidepressant drugs test system.

(b)*Classification.* Class II (special controls). A tricyclic antidepressant drugs test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs ( *e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). PART 864—HEMATOLOGY AND PATHOLOGY DEVICES 38. The authority citation for part 864 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 39. In § 864.5400, revise paragraph

(b)to read as follows: § 864.5400 Coagulation instrument.

(b)*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 40. In § 864.5425, revise paragraph

(b)to read as follows: § 864.5425 Multipurpose system for in vitro coagulation studies.

(b)*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 41. In § 864.6550, revise paragraph

(b)to read as follows: § 864.6550 Occult blood test.

(b)*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 42. In § 864.7040, revise paragraph

(b)to read as follows: § 864.7040 Adenosine triphosphate release assay.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 43. In § 864.7275, revise paragraph

(b)to read as follows: § 864.7275 Euglobulin lysis time tests.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 44. In § 864.7300, revise paragraph

(b)to read as follows: § 864.7300 Fibrin monomer paracoagulation test.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The special control for this device is FDA's “In Vitro Diagnostic Fibrin Monomer Paracoagulation Test.” See § 864.1(d) for information on obtaining this document. 45. In § 864.7340, revise paragraph

(b)to read as follows: § 864.7340 Fibrinogen determination system.

(b)*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 46. In § 864.7375, revise paragraph

(b)to read as follows: § 864.7375 Glutathione reductase assay.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 47. In § 864.7415, revise paragraph

(b)to read as follows: § 864.7415 Abnormal hemoglobin assay.

(b)*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 48. In § 864.7455, revise paragraph

(b)to read as follows: § 864.7455 Fetal hemoglobin assay.

(b)*Classification.* Class II (special controls). A fetal hemoglobin stain intended for use with a fetal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 49. In § 864.7500, revise paragraph

(b)to read as follows: § 864.7500 Whole blood hemoglobin assays.

(b)*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 50. In § 864.7720, revise paragraph

(b)to read as follows: § 864.7720 Prothrombin consumption test.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 51. In § 864.7735, revise paragraph

(b)to read as follows: § 864.7735 Prothrombin-proconvertin test and thrombotest.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 52. In § 864.8150, revise paragraph

(b)to read as follows: § 864.8150 Calibrator for cell indices.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 53. In § 864.8165, revise paragraph

(b)to read as follows: § 864.8165 Calibrator for hemoglobin or hematocrit measurement.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 54. In § 864.8175, revise paragraph

(b)to read as follows: § 864.8175 Calibrator for platelet counting.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 55. In § 864.8185, revise paragraph

(b)to read as follows: § 864.8185 Calibrator for red cell and white cell counting.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 56. In § 864.8625, revise paragraph

(b)to read as follows: § 864.8625 Hematology quality control mixture.

(b)*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. 57. In § 864.9400, revise paragraph

(b)to read as follows: § 864.9400 Stabilized enzyme solution.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES 58. The authority citation for part 866 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 59. In § 866.2900, revise paragraph

(b)to read as follows: § 866.2900 Microbiological specimen collection and transport device.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. 60. In § 866.3395, revise paragraph

(b)to read as follows: § 866.3395 Norovirus serological reagents.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document. 61. In § 866.5210, revise paragraph

(b)to read as follows: § 866.5210 Ceruloplasmin immunological test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. 62. In § 866.5470, revise paragraph

(b)to read as follows: § 866.5470 Hemoglobin immunological test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. 63. In § 866.5620, revise paragraph

(b)to read as follows: § 866.5620 Alpha -2-macroglobulin immunological test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. 64. In § 866.5630, revise paragraph

(b)to read as follows: § 866.5630 Beta -2-microglobulin immunological test system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. 65. In § 866.5750, revise paragraph

(b)to read as follows: § 866.5750 Radioallergosorbent

(RAST)immunological test system.

(b)*Classification.* Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. Table 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent

(RAST)Immunological Test Systems Allergen code Allergen product Source (taxonomical name) Grass Pollens g1 Sweet vernal grass *Anthoxanthum odoratum.* g3 Cocksfoot grass, Orchard grass *Dactylis glomerata.* g4 Meadow fescue *Festuca elatior.* g5 Rye-grass (perennial rye grass) *Lolium perenne.* g7 Common reed (common reed grass) *Phragmites communis.* g8 Meadow grass, Kentucky blue (June grass) *Poa pratensis.* g9 Redtop, Bentgrass *Agrostis stolonifera* , *Agrostis gigantea* ( *Agrostis alba* ). g11 Brome grass *Bromus inermis.* g12 Cultivated rye (cultivated rye grass) *Secale cereale.* g13 Velvet grass *Holcus lanatus.* g14 Cultivated oat (cultivated oat grass) *Avena sativa.* g15 Cultivated wheat (cultivated wheat grass) *Triticum aestivum* ( *Triticum* spp.). g16 Meadow foxtail (meadow foxtail grass) *Alopecurus pratensis.* g17 Bahia grass *Paspalum notatum.* g24 Wheat grass, Western *Agropyron smithii* ( *Elymus smithii* ). g30 Bluegrass, annual *Poa annua.* g70 Wild rye grass *Elymus triticoides* *Elymus condensatus.* g71 Canary grass *Phalaris arundinacea.* g201 Barley, cultivated *Hordeum vulgare.* g202 Maize, corn (cultivated corn) *Zea mays.* g203 Salt grass *Distichlis spicata.* g204 False oat-grass *Arrhenatherum elatius.* g216 Cyn d 1 *Cynodon dactylon.* g701 Phl p 1.0102, Phl p 5.0101 *Phleum pratense.* g702 Phl p 7.0101 *Phleum pratense.* g703 Phl p 12.0101 *Phleum pratense.* Weed Pollens w2 Western ragweed *Ambrosia psilostachya.* w4 False ragweed *Ambrosia acanthicarpa* ( *Franseria acanthicarpa* ). w5 Wormwood *Artemisia absinthium* *Artemisia annua.* w6 Mugwort *Artemisia vulgaris.* w7 Marguerite, ox-eye daisy *Chrysanthemum leucanthemum.* w8 Dandelion *Taraxacum vulgare* , *Taraxacum officinale.* w9 Plantain (English), Ribwort *Plantago lanceolata.* w10 Goosefoot, lamb's quarters *Chenopodium album.* w11 Saltwort (prickly), Russian thistle *Salsola kali* ( *Salsola pestifer* ). w12 Goldenrod *Solidago virgaurea* ( *Solidago* spp.). w13 Cocklebur, common *Xanthium commune.* w14 Common pigweed (rough pigweed) *Amaranthus retroflexus.* w15 Scale, Lenscale *Atriplex lentiformis.* w16 Rough marsh elder *Iva ciliate* , *Iva annua.* w17 Firebush (Kochia) *Kochia scoparia.* w18 Sheep sorrel *Rumex acetosella.* w19 Wall pellitory *Parietaria officinalis.* w20 Nettle (Common stinging nettle) *Urtica dioica.* w21 Wall pellitory *Parietaria judaica.* w22 Japanese hop (careless weed) *Humulus japonicas* ( *Humulus scandens* ). w23 Yellow dock, Yellow dockweed *Rumex crispus.* w24 Spiny pigweed *Amaranthus spinosus.* w27 Carnation *Dianthus* spp. w28 Rose *Rosa rugosa.* w33 Clover *Trifolium pratense.* w35 Mexican tea *Chenopodium ambrosioides.* w36 Rabbit bush *Ambrosia deltoidea* ( *Franseria deltoides* ). w37 Salt bush, annual *Atriplex wrightii.* w39 Water hemp, Western *Amaranthus rudis* ( *Acnida tamariscina* ). w41 Burrobrush *Hymenoclea salsola.* w42 Poverty weed *Baccharis neglecta.* w43 Common sagebrush *Artemisia tridentata.* w45 Alfalfa *Medicago sativa.* w46 Dog fennel *Eupatorium capillifolium.* w53 Geranium *Geranium* spp. w67 Groundsel bush *Baccharis halimifolia.* w69 Iodine bush *Allenrolfea occidentalis.* w70 Ragweed, slender *Ambrosia confertiflora.* w75 Wing scale (wingscale) *Atriplex canescens.* w82 Careless weed *Amaranthus palmeri* , *Amaranthus hybridus.* w90 Japanese hop *Humulus japonicas* ( *Humulus scandens* ). w203 Rape (rape pollen) *Brassica napus.* w204 Sunflower *Helianthus annuus.* w206 Camomile *Matricaria chamomilla.* w207 Lupin *Lupinus* spp. w210 Sugar-beet *Beta vulgaris.* w211 Par j 2.0101 *Parietaria judaica.* w231 Art v 1 *Artemisia vulgaris* (Mugwort). w232 Sal k 1 *Salsola kali.* w233 Art v 3 *Artemisa vulgaris* (LTP, Mugwort). w234 Pla l 1 *Plantago lanceolata.* w235 Che a 1.0101 *Chenopodium album.* w236 Mer a 1.0101 *Mercurialis annua.* a753 Art v 1 *Artemisia vulgaris* (Mugwort weed). Tree Pollens t1 Box-elder (Maple) *Acer negundo* , *Acer saccharum.* t2 Gray alder, speckled alder (alder) *Alnus incana.* t4 Hazel, hazelnut *Corylus avellana* , *Corylus americana.* t5 American beech (beech) *Fagus grandifolia* ( *Fagus americana* ). t6 Mountain juniper, Mountain cedar *Juniperus ashei* ( *Juniperus sabinoides* ). t8 Elm *Ulmus americana.* t9 Olive *Olea europaea.* t10 Walnut *Juglans californica* , *Juglans nigra.* t11 Maple leaf sycamore, London plane, Plane tree *Platanus acerifolia.* t61 Sycamore *Platanus occidentalis.* t12 Willow *Salix caprea* , *Salix nigra.* t14 Cottonwood (Eastern Cottonwood/Black Cottonwood) *Populus deltoides.* t15 White ash *Fraxinus americana.* t16 White pine *Pinus strobus.* t18 Eucalyptus, gum-tree *Eucalyptus globulus* ( *Eucalyptus* spp.). t19/t26 Acacia *Acacia longifolia* ( *Acacia* spp.). t20 Mesquite *Prosopis glandulosa/* *Prosopis juliflora.* t21 Melaleuca, cajeput tree *Melaleuca quinquenervia* ( *Melaleuca leucadendron* ). t22 Pecan, hickory *Carya illinoinensis* ( *Carya pecan* ). t23 Italian/Mediterranean/funeral cypress *Cupressus sempervirens.* t24 Japanese cypress *Chamaecyparis obtusa* ( *Chamaecyparis* spp.). t25 Ash *Fraxinus excelsior.* t27 Maple, red *Acer rubrum.* t29 Acacia *Acacia* spp. t30 Birch, white *Betula populifolia.* t32 Willow, black *Salix nigra.* t33 Ash, Arizona *Fraxinus velutina.* t35 Cedar, salt *Tamarix gallica.* t37 Bald cypress (white bald cypress) *Taxodium distichum.* t38 Elm, Chinese/Siberian *Ulmus pumila.* t40 Hazelnut tree *Corylus americana.* t41 White hickory *Carya alba* ( *Carya tomentosa* ). t42 Oak, red *Quercus rubra.* t43 Loblolly pine *Pinus taeda.* t44 Hackberry *Celtis occidentalis.* t45 Cedar elm *Ulmus crassifolia.* t47 Juniper, one seed *Juniperus monosperma.* t48 Pine, lodgepole *Pinus contorta.* t49 Pine, ponderosa *Pinus ponderosa.* t50 Beech, European *Fagus sylvatica.* t51 Tree of Heaven *Ailanthus altissima.* t52 Western white pine *Pinus monticola.* t54 Russian olive *Elaeagnus angustifolia.* t55 Scotch broom *Cytisus scoparius.* t56 Bayberry *Myrica cerifera.* t57 Red cedar *Juniperus virginiana.* t60 Western juniper *Juniperus occidentalis.* t61 Sycamore *Platanus occidentalis.* t70 Mulberry (white mulberry) *Morus alba.* t71 Red mulberry *Morus rubra.* t72 Queen palm *Arecastrum romanzoffiamon.* t73 Australian pine *Casuarina equisetifolia.* t77 Oak mix (red, white, black) *Quercus* spp. t80 Japanese cypress *Chamaecyparis obtusa.* t81 Japanese alder *Alnus japonica.* t83 Mango tree *Mangifera indica.* t90 Walnut, black *Juglans nigra.* t96 Poplar, white (poplar) *Populus alba.* t103/t218 Virginia live oak (live oak) *Quercus virginiana.* t105 Pepper tree *Schinus molle.* t110 Orange tree *Citrus sinensis.* t201 Spruce, Norway spruce *Picea abies* ( *Picea excelsa* ). t202 Alder, smooth *Alnus incana* spp. * Rugosa* ( *Alnus rugosa* ). t203 Horse chestnut *Aesculus hippocastanum.* t205 Elder *Sambucus nigra.* t206 Chestnut *Castanea sativa.* t207 Douglas fir *Pseudotsuga menziesii* ( *Pseudotsuga taxifolia* ). t208 Linden *Tilia cordata.* t209 Horn beam *Carpinus betulus.* t210 Privet *Ligustrum vulgare.* t211 Sweet gum *Liquidambar styraciflua.* t212 Cedar *Libocedrus decurrens.* t213 Pine *Pinus radiata.* t214 Date palm *Phoenix canariensis.* t215 Lilac *Syringa vulgaris.* t217 Pepper tree *Schinus molle.* t217 Red alder *Alnus rubra.* t218 Virginia live oak *Quercus virginiana.* t218 Bayberry (bayberry/sweet gale) *Myrica gale.* t219 Palo verde *Cercidium floridum.* t219 Red cedar *Juniperus virginiana.* t220 Bet v 4 *Betula verrucosa* (Birch). t221 Bet v 2.0101, Bet v 4 *Betula verrucosa* (Birch). t222 Cypress (Arizona cypress) *Cupressus arizonica.* t223 Oil palm *Elaeis guineensis.* t224 Ole e 1 *Olea europaea.* t225 Bet v 6 *Betula verrucosa* (Birch). t226 Cup a 1 *Cupressus arizonica.* t227 Ole e 7 *Olea Europaea.* t228 Aspen, quaking *Populus tremuloides.* t229 Eastern hemlock *Tsuga canadensis.* t230 Redwood (sequoia) *Sequoia sempervirens.* t232 Pussy willow *Salix discolor.* t240 Ole e 9.0101 *Olea Europaea.* t241 Pla a 1.0101 *Platanus acerifolia.* t242 Pla a 2 *Platanus acerifolia.* t243 Pla a 3.0101 *Platanus acerifolia.* t244 Cor a 1.0103 *Corylus avellana.* t245 Aln g 1.0101 *Alnus glutinosa.* t246 Cry j 1 *Cryptomeria japonica.* t280 Locust tree *Robinia pseudoacacia.* t401 Brazilian peppertree *Schinus terebinthifolius.* t402 Mastic tree *Pistacia lentiscus.* t404 Tree of heaven *Ailanthus altissima.* t406 Date palm *Phoenix dactylifera.* a482 Ole e 1 *Olea europaea* (Olive Oil). Mites d207 Blo t 5.0101 *Blomia tropicalis.* d208 Lep d 2.0101 *Lepidoglyphus destructor.* Microorganisms, Molds, Yeast m1 *Penicillium chrysogenum* ( *Penicillium notatum* ) *Penicillium chrysogenum* ( *Penicillium notatum* ). m2 *Cladosporium herbarum* ( *Hormodendrum* ) *Cladosporium herbarum* ( *Hormodendrum* ). m3 *Aspergillus fumigatus* *Aspergillus fumigatus.* m4 *Mucor racemosus* *Mucor racemosus.* m5 *Candida albicans* *Candida albicans.* m7 *Botrytis cinerea* *Botrytis cinerea.* m8 *Drechslera halodes* ( *Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum* ) *Drechslera halodes* ( *Setomelanomma rostrata, Helminthosporium halodes.* m9 *Fusarium moniliforme* ( *Fusarium proliferatum* ) *Fusarium moniliforme* ( *Fusarium proliferatum* ). m10 *Stemphylium botryosum* *Stemphylium herbarum* ( *Stemphylium botryosum* ). m11 *Rhizopus nigricans* *Rhizopus nigricans.* m12 *Aureobasidium pullulans* *Aureobasidium pullulans.* m13 *Phoma betae* *Phoma betae.* m14 *Epicoccum purpurascens* *Epicoccum purpurascens* ( *Epicoccum nigrum* ). m15 *Trichoderma viride* *Trichoderma viride.* m16 *Curvularia lunata* *Curvularia lunata* , *Curvularia specifera* ( *K923044* ). m17 *Cladosporium fulvum* *Cladosporium fulvum.* m18 *Fusarium culmorum* *Fusarium culmorum.* m19 *Aspergillus versicolor* *Aspergillus versicolor.* m20 *Mucor mucedo* *Mucor mucedo.* m21 *Aspergillus clavatus* *Aspergillus clavatus.* m22 *Micropolyspora faeni* *Saccharopolyspora rectivirgula* ( *Micropolyspora faeni* ). m23 *Thermoactinomyces vulgaris* *Thermoactinomyces vulgaris.* m24 *Stachybotrys atra* *Stachybotrys chartarum* ( *Stachybotrys atra* ). m24 *Paecilomyces* spp *Paecilomyces* spp. m25 *Aspergillus versicolor* *Aspergillus versicolor.* m25 *Penicillium brevicompactum* *Penicillium brevicompactum.* m26 *Cladosporium cladosporioides* *Cladosporium cladosporioides.* m26 *Penicillium citrinum* *Penicillium citrinum.* m27 *Penicillium* spp *Penicillium* spp. m29 *Aspergillus repens* *Aspergillus repens.* m30 *Penicillium roqueforti* *Penicillium roqueforti.* m32 *Cladosporium cladosporioides* *Cladosporium cladosporioides.* m34 *Serpula lacrymans* *Serpula lacrymans.* m36 *Aspergillus terreus* *Aspergillus terreus.* m37 *Trichophyton mentagrophytes* *Trichophyton mentagrophytes.* m40 *Aspergillus amstelodami* *Aspergillus amstelodami.* m43 *Saccharomyces Carlsberg* *Saccharomyces carlsbergensis.* m44 *Saccharomyces cerevisiae* *Saccharomyces cerevisiae.* m45 *Hormodendrum hordei* *Hormodendrum hordei.* m46 *Bipolaris spicifera* *Bipolaris spicifera.* m47 *Aspergillus nidulans* *Aspergillus nidulans.* m48 *Aspergillus oryzae* *Aspergillus oryzae.* m49 *Fusarium oxysporum* *Fusarium oxysporum.* m50 *Micropolyspora faeni* *Saccharopolyspora rectivirgula* ( *Micropolyspora faeni* ). m51 *Thermoactinomyces vulgaris* *Thermoactinomyces vulgaris.* m53 *Microspora canis* *Microsporum canis* ( *Microspora canis* ). m54 *Aspergillus flavus* *Aspergillus flavus.* m63 *Helminthosporium intersemin* *Helminthosporium intersemin.* m66 *Mucor plumbeus* *Mucor plumbeus.* m67 *Mycogone* *Mycogone perniciosa.* m68 *Nigrospora oryzae* *Nigrospora oryzae.* m69 *Rhodotorula* *Rhodotorula rubra* ( *Rhodotorula mucilaginosa* ). m70 *Malassezia furfur* ( *Pityrosporum orbiculare* ) *Malassezia furfur* ( *Pityrosporum orbiculare* ). m71 *Spondylocladium* *Spondylocladium* spp. m72 *Epidermophyton* *Epidermophyton floccosum.* m73 *Epicoccum nigrum* *Epicoccum purpurascens* ( *Epicoccum nigrum* ). m80 *Staphylococcal enterotoxin A* ( *Sta a SEA* ) *Staphylococcus aureus.* m80 *Helminthosporium* spp *Helminthosporium* spp. m81 *Staphylococcal enterotoxin B* ( *Sta a SEB* ) *Staphylococcus aureus.* m88 *Stemphylium solani* *Stemphylium solani.* m93 *Gliocladium fimbriatum* *Gliocladium fimbriatum.* m94 *Phycomyces blakesleeanus* *Phycomyces blakesleeanus.* m201 *Tilletia tritici* ( *Ustilago nuda, Ustilago tritici* ) (Barley smut) *Tilletia tritici* ( *Ustilago nuda, Ustilago tritici* ). m202 *Acremonium kiliense* ( *Cephalosporium acremonium* ) *Acremonium kiliense* ( *Cephalosporium acremonium* ). m203 *Trichosporon pullulans* *Trichosporon pullulans.* m204 *Ulocladium chartarum* *Ulocladium chartarum.* m205 *Trichophyton rubrum* *Trichophyton rubrum.* m207 *Aspergillus niger* *Aspergillus niger.* m208 *Chaetomium globosum* *Chaetomium globosum.* m209 *Penicillium frequentans* *Penicillium glabrum* ( *Penicillium frequentans* ). m209 *Stachybotrys chartarum* *Stachybotrys chartarum* ( *Stachybotrys atra* ). m210 *Trichophyton mentagrophytes var. goetzii* *Trichophyton mentagrophytes var. goetzii.* m211 *Trichophyton mentagrophytes var. interdigitale* *Trichophyton mentagrophytes var. interdigitale.* m211 Oat smut *Ustilago avenae.* m212 *Micropolyspora faeni* *Saccharopolyspora rectivirgula* ( *Micropolyspora faeni* ). m212 *Geotrichum candidum* *Geotrichum candidum.* m213 Bermuda grass smut *Ustilago cynodontis.* m214 Johnson grass smut *Sphacelotheca cruenta.* m215 Corn smut *Ustilago maydis.* m218 Asp f 1.0101 *Aspergillus fumigatus.* a3050 Asp r 1 *Aspergillus restrictus.* m219 Asp f 2 *Aspergillus fumigatus.* m220 Asp f 3.0101 *Aspergillus fumigatus.* m221 Asp f 4 *Aspergillus fumigatus.* m222 Asp f 6.0101 *Aspergillus fumigatus.* m223 *Staphylococcal enterotoxin C* ( *Sta a SEC* ) *Staphylococcus aureus.* m224 *Staphylococcal enterotoxin D* ( *Sta a SED* ) *Staphylococcus aureus.* m226 *Staphylococcal enterotoxin TSST* ( *Sta a TSST* ) *Staphylococcus aureus.* m227 *Malassezia* spp. ( *Pityrosporum* spp.) *Malassezia* spp. ( *Pityrosporum* spp.). m228 *Aspergillus flavus.* m229 Alt a 1.0101 *Alternaria alternata* ( *Alternaria tenuis* ). m230 Alt a 6.0101 *Alternaria alternata* ( *Alternaria tenuis* ). m231 Cla h 8.0101 *Cladosporium herbarum* ( *Hormodendrum* ). m300 *Eurotium* spp *Eurotium* spp. m304 *Aspergillus oryzae* *Aspergillus oryzae.* m305 *Penicillium brevicompactum* *Penicillium brevicompactum.* m309 *Aspergillus terreus* *Aspergillus terreus.* m310 *Aspergillus nidulans* *Aspergillus nidulans.* m311 *Aspergillus flavus* *Aspergillus flavus.* m312 *Aspergillus clavatus* *Aspergillus clavatus.* Epidermal & Animal e6 Guinea pig epithelium *Cavia porcellus.* e7 Pigeon droppings *Columba palumbus* , *Columba livia.* e25 Chicken serum *Gallus domesticus* ( *Gallus gallus domesticus; Gallus* spp.). e26 Parrot serum *Psittacoidea* spp. e62 Camel *Camelus dromedaries.* e70 Goose feathers *Anser anser.* e71 Mouse epithelium *Mus musculus* ( *Mus* spp.). e73 Rat epithelium *Rattus norvegicus.* e74 Rat urine proteins *Rattus norvegicus* , *Rattus rattus.* e75 Rat serum proteins *Rattus norvegicus* , *Rattus rattus.* e76 Mouse serum proteins *Mus musculus* ( *Mus* spp.). e77 Budgerigar droppings *Melopsittacus undulatus.* e78 Budgerigar feathers *Melopsittacus undulatus.* e79 Budgerigar serum proteins *Melopsittacus undulatus.* e80 Goat epithelium *Capra hircus.* e81 Sheep epithelium *Ovis aries* ( *Ovis* spp.). e82 Rabbit epithelium *Oryctolagus cuniculus* ( *Oryctolagus* spp.). e83 Swine epithelium *Sus scrofa* ( *Sus scrofa domesticus; Sus* spp.). e84 Hamster epithelium *Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.* e85 Chicken feathers *Gallus domesticus* ( *Gallus gallus domesticus; Gallus* spp.). e86 Duck feathers *Anas platyrhynchos.* e87 Rat epithelium, serum proteins, and urine proteins *Rattus norvegicus* *Rattus rattus.* e88 Mouse epithelium, serum proteins, and urine proteins (mouse) *Mus musculus* ( *Mus* spp.). e89 Turkey feathers *Meleagris gallopavo.* e90 Budgerigar serum proteins, feathers, and droppings *Melopsittacus undulatus.* e91 Pigeon serum proteins, feathers, and droppings *Streptopelia roseogrisea* , *Psittacidae* spp. e92 Parrot serum proteins, feathers, and droppings *Ara* spp. e93 Pigeon serum proteins *Streptopelia roseogrisea.* e94 Fel d 1.0101 *Felis domesticus.* a345 Fel d 1 *Felis domesticus.* e98 Parrot droppings *Psittacoidea* spp. e101 Can f 1.0101 *Canis familiaris* ( *Canis domesticus* ). a174 Can f 1 *Canis familiaris* ( *Canis domesticus* ). e102 Can f 2.0101 *Canis familiaris* ( *Canis domesticus* ). e196 Parakeet feathers *Nymphicus hollandicus.* e197 Parakeet droppings *Nymphicus hollandicus.* e198 Parakeet serum *Nymphicus hollandicus.* e199 Canary bird serum *Serinus canarius.* e200 Canary bird droppings *Serinus canarius.* e201 Canary bird feathers (Canary feathers) *Serinus canarius.* e202 Reindeer epithelium *Rangifer tarandus.* e203 Mink epithelium *Mustela* spp. e204 Bos d 6 *Bos domesticus* ( *Bos taurus; Bos* spp.). e205 Horse, serum proteins *Equus caballus* ( *Equus* spp.). e206 Rabbit, serum proteins *Oryctolagus cuniculus* ( *Oryctolagus* spp.). e208 Chinchilla epithelium *Chinchilla laniger.* e209 Gerbil epithelium *Meriones unguiculatus.* e210 Fox epithelium *Vulpes vulpes.* e211 Rabbit, urine proteins *Oryctolagus cuniculus* ( *Oryctolagus* spp.). e212 Swine, urine proteins *Sus scrofa* ( *Sus scrofa domesticus; Sus* spp.). e213 Parrot feathers *Ara* spp. e214 Finch feathers *Lonchura domestica.* e215 Pigeon feathers *Streptopelia roseogrisea* ( *Streptopelia* spp.), *Columbia* spp. e216 Deer epithelium *Dama dama.* e217 Ferret epithelium *Mustela putorius.* e218 Chicken droppings *Gallus domesticus* ( *Gallus gallus domesticus; Gallus* spp.). e219 Chicken, serum proteins *Gallus domesticus* ( *Gallus gallus domesticus; Gallus* spp.). e220 Fel d 2, Cat serum albumin *Felis domesticus.* e221 Can f 3 *Canis familiaris* ( *Canis domesticus* ) ( *Dog serum albumin* ). e222 Swine serum albumin (Sus s PSA) *Sus scrofa* ( *Sus scrofa domesticus; Sus* spp.). e225 Lovebird feathers *Psittacoidea agapomis.* e226 Can f 5.0101 *Canis familiaris.* e227 Equ c 1.0101 *Equus caballus.* e228 Fel d 4.0101 *Felis domesticus.* e230 Equ c 3 *Equus caballus.* e231 Mus m 1 *Mus musculus.* Food f9 Rice *Oryza sativa.* f12 Pea (green pea) *Pisum sativum.* f15 White bean *Phaseolus vulgaris.* f19 Cayenne pepper *Capsicum frutescens* ( *Capsicum annum* ). f21 Sugar cane *Saccharum officinarum.* f22 Raspberry *Rubus idaeus.* f26 Pork *Sus scrofa* ( *Sus scrofa domesticus; Sus* spp.). f29 Watermelon *Citrullus lanatus* ( *Citrullus vulgaris* ). f31 Carrot *Daucus carota.* f32 Oyster mushroom *Pleurotus ostreatus.* f33 Orange *Citrus sinensis.* f35 Potato *Solanum tuberosum.* f43 Mother's milk *Homo sapiens.* f44 Strawberry *Fragaria vesca* ( *Fragaria* spp.). f45 Yeast, baker's *Saccharomyces cerevisiae.* f46 Pepper, Red *Capsicum annuum.* f47 Garlic *Allium sativum.* f48 Onion *Allium cepa.* f49 Apple *Malus x domestica* ( *Malus* spp.). f51 Bamboo shoot *Phyllostachys pubescens.* f52 Cacao/chocolate *Theobroma cacao.* f54 Sweet potato *Ipomoea batatas.* f55 Common millet *Panicum miliaceum.* f56 Foxtail millet *Setaria italica.* f57 Japanese millet *Echinochloa crus-galli.* f58 Pacific squid *Todarodes pacificus.* f59 Octopus *Octopus vulgaris* ( *Octopus* spp.). f63 Kefir NA. f67 Parmesan cheese NA. f81 Cheese, cheddar type NA. f82 Cheese, mold type NA. f83 Chicken *Gallus domesticus* ( *Gallus gallus domesticus; Gallus* spp.). f86 Parsley *Petroselinum crispum.* f87 Melon *Cucumis melo Cucumis melo + Citrullus lanatus.* f88 Mutton

(lamb)*Ovis aries* ( *Ovis* spp.). f90 Malt *Hordeum vulgare.* f92 Banana *Musa* spp. f93 Cacao *Theobroma cacao.* f94 Pear *Pyrus communis* ( *Pyrus* spp.). f97 Yam *Dioscorea* spp. *Dioscorea opposita.* f97 Chamomile tea *Matricaria chamomilla.* f98 Gliadin *Triticum aestivum* ( *Triticum* spp.). f102 Cantaloupe *Cucumis melo var. cantalupensis.* f105 Chocolate *Theobroma cacao.* f109 Cottonseed *Gossypium hirsutum.* f110 Giant radish *Raphanus sativus.* f118 Zucchini *Cucurbita pepo.* f119 Radish *Raphanus sativus.* f120 Venison *Capreolus capeolus.* f121 Pinto bean *Phaseolus vulgaris.* f122 Cheese, American NA. f127 Black-eyed pea *Vigna unguiculata.* f131 Black Olive *Olea europaea.* f136 Red beet *Beta vulgaris var. conditiva.* f139 Goat's Cheese *Capra aegagrus.* f140 Bran NA. f141 Corn (vegetables) *Zea mays.* f152 Green bell pepper *Capsicum annuum.* f155 Brewer's yeast *Saccharomyces carlsbergensis.* f157 Duck *Anas domesticus.* f158 Goose *Anser anser.* f160 Camembert cheese NA. f162 Nectarine *Prunus persica var. nucipersica.* f163 Kohlrabi *Brassica oleracea var. gongylodes.* f65 Perch f166 Leek *Allium porrum.* f170 Cheese (Switzerland) (Swiss cheese) NA. f174 Fig *Ficus carica.* f177 Cranberry *Vaccinium macrocarpon.* f179 Raisin *Vitis* spp. f182 Lima bean *Phaseolus lunatus.* f198 Flaxseed (bruised grain) *Linum usitatissimum.* f199 Untreated native milk *Bos domesticus* ( *Bos taurus; Bos* spp.). f208 Lemon *Citrus limon.* f209 Grapefruit *Citrus paradisi.* f210 Pineapple *Ananas comosus.* f211 Blackberry *Rubus fruticosus.* f212 Mushroom (champignon) *Agaricus hortensis* ( *Agaricus* spp.). f213 Rabbit *Oryctolagus cuniculus* ( *Oryctolagus* spp.). f214 Spinach *Spinacia oleracea.* f215 Lettuce *Lactuca sativa.* f216 Cabbage *Brassica oleracea var. capitata.* f217 Brussels sprouts *Brassica oleracea var. gem.* f218 Paprika, sweet pepper *Capsicum annuum.* f219 Fennel seed *Foeniculum vulgare.* f219 Sage *Salvia officinalis.* f220 Cinnamon *Cinnamomum* spp. f221 Coffee *Coffea* spp. f222 Tea *Camellia sinensis.* f223 Green olive *Olea europaea.* f225 Summer squash, pumpkin *Cucurbita pepo.* f225 Pumpkin *Cucurbita maxima.* f226 Pumpkin seed *Cucurbita pepo.* f227 Sugar-beet seed *Beta vulgaris.* f229 Safflower Seed *Carthamus tinctorius.* f231 Milk, boiled *Bos domesticus* ( *Bos taurus; Bos* spp.). f234 Vanilla *Vanilla planifolia.* f237 Apricot *Prunus armeniaca.* f241 Gouda cheese NA. f242 Cherry *Prunus avium.* f244 Cucumber *Cucumis sativus.* f246 Guar, guar gum *Cyamopsis tetragonoloba.* f247 Honey NA. f248 Rosemary *Rosmarinus officinalis.* f254 Plaice *Pleuronectes platessa.* f255 Plum *Prunus domestica* , *Prunus americana.* f258 Squid *Loligo* spp. f259 Grape *Vitis vinifera* ( *Vitis* spp.). f260 Broccoli *Brassica oleracea var. italica* ( *Brassica oleracea var. cultivar* ). f261 Asparagus *Asparagus officinalis.* f262 Aubergine, eggplant *Solanum melongena.* f263 Green pepper *Piper nigrum* , *Capsicum annuum.* f264 Eel *Anguilla anguilla.* f265 Caraway *Carum carvi.* f265 Cumin *Cuminum cyminum.* f266 Mace *Myristica fragrans.* f267 Cardamon *Elettaria cardamomum.* f268 Clove *Syzygium aromaticum.* f269 Basil *Ocimum basilicum.* f270 Ginger *Zingiber officinale.* f271 Anise *Pimpinella anisum.* f272 Tarragon *Artemisia dracunculus.* f273 Thyme *Thymus vulgaris.* f274 Marjoram *Origanum majorana.* f275 Lovage *Levisticum officinale.* f276 Fennel, fresh *Foeniculum vulgare.* f277 Dill *Anethum graveolens.* f278 Bay leaf *Laurus nobilis.* f279 Chili pepper *Capsicum frutescens.* f280 Black pepper *Piper nigrum.* f281 Curry (Santa Maria) NA. f282 Nutmeg *Myristica fragrans.* f283 Oregano *Origanum vulgare.* f284 Turkey meat *Meleagris gallopavo.* f285 Elk/moose meat *Alces* spp. f286 Mare's milk *Equus caballus* ( *Equus* spp.). f287 Red kidney bean *Phaseolus vulgaris.* f288 Blueberry *Vaccinium myrtillus* ( *Vaccinium* spp.). f289 Date *Phoenix dactylifera.* f291 Cauliflower *Brassica oleracea var. botrytis.* f292 Guava *Psidium guajava.* f293 Papaya *Carica papaya.* f294 Passion fruit, Maracuja *Passiflora edulis* ( *Passiflora* spp.). f295 Carambola *Averrhoa carambola.* f296 Carob *Ceratonia siliqua.* f297 Gum Arabic *Acacia senegal* ( *Acacia* spp.). f298 Tragacanth *Astragalus* spp. f299 Sweet chestnut (chestnut) *Castanea sativa.* f300 Pinto bean *Phaseolus* spp. f301 Persimmon (kaki fruit, sharon) *Diospyros kaki.* f302 Mandarin (tangerine, clementine, satsumas) *Citrus reticulata.* f305 Fenugreek *Trigonella foenum-graecum.* f306 Lime *Citrus aurantifolia.* f307 Hake *Merluccius merluccius.* f308 Sardine (pilchard) *Sardina pilchardus.* f310 Blue vetch *Lathyrus sativus.* f311 Megrim *Lepidorhombus whiffiagonis.* f315 Green bean *Phaseolus vulgaris.* f316 Rape seed *Brassica napus.* f317 Coriander *Coriandrum sativum.* f318 Jack fruit *Artocarpus heterophyllus.* f319 Beetroot *Beta vulgaris.* f320 Crayfish *Astacus astacus.* f321 Horse meat *Equus caballus* ( *Equus* spp.). f322 Red currant *Ribes sylvestre.* f324 Hop (fruit cone) *Humulus lupulus.* f325 Saffron *Colchicum autumnale.* f328 Fig *Ficus carica.* f329 Watermelon *Citrullus lanatus.* f330 Rose hip *Rosa* spp. f331 Saffron *Crocus sativus.* f332 Mint *Mentha piperita.* f333 Linseed *Linum usitatissimum.* f336 Jujube *Ziziphus jujuba.* f336 Wine vinegar *Vitis vinifera* ( *Vitis* spp.). f337 Sole *Solea solea.* f337 English sole *Parophrys vetulus.* f338 Wine, white *Vitis vinifera* ( *Vitis* spp.). f339 Allspice *Pimenta dioica.* f339 Wine, red *Vitis vinifera* ( *Vitis* spp.). f341 Cranberry *Vaccinium oxycoccus* , *Vaccinium macrocarpon.* f342 Olive (black, fresh) *Olea europaea.* f343 Raspberry *Rubus idaeus.* f344 Sage *Salvia officinalis.* f346 Chives *Allium schoenoprasum.* f347 Quinoa *Chenopodium quinoa.* f348 Litchi *Litchi chinensis.* f349 Chum salmon roe *Oncorhynchus keta.* f358 Artichoke *Cynara scolymus.* f360 Yogurt NA. f368 Black bass *Micropterus dolomieu* ( *Micropterus dolomieui* ). f374 Karaya gum *Sterculia urens.* f375 Horseradish *Armoracia rusticana.* f377 Maple syrup NA. f379 Okra *Abelmoschus esculentus.* f382 Beet, sugar *Beta vulgaris var. altissima.* f401 Loquat *Eriobotrya japonica.* f402 Fig *Ficus carica.* f403 Brewer's yeast *Saccharomyces cerevisiae.* f405 Mint *Mentha* spp. f406 Arugula *Eruca vesicaria.* House Dust h1 Greer Labs., Inc NA. h2 Hollister-Stier Labs NA. h6 Japan NA. Venoms & Insects i7 Midge *Chironomus yoshimatsui.* i8 Moth *Bombyx mori* , *Heterocera* spp. i47 Water flea *Daphnia* spp. i49 Deer fly *Chrysops* spp. i51 Black ant *Camponotus pennsylvanicus.* i54 Flea mix (dog/cat), common flea *Ctenocephalides* spp. i71 Mosquito *Aedes communis* , *Aedes* spp. * and Culex* spp. i72 Green nimitti *Cladotanytarsus lewisi.* i73 Blood worm *Chironomus thummi* , *Chironomusri parius* , *Chironomus* spp. i75 European hornet *Vespa crabro.* i76 Berlin beetle *Trogoderma angustum.* i77 European paper wasp *Polistes dominulus.* i78 Fly *Musca domestica.* i80 Bumblebee *Bombus pennsylvanicus.* i201 Horse bot fly *Gasterophilus intestinalis.* i202 Grain weevil *Sitophilus granarius.* i203 Mediterranean flour moth *Ephestia kuehniella* ( *Anagasta kuehniella* ). i204 Horse fly *Tabanus* spp. i205 Bumblebee *Bombus terrestris.* i208 Api m 1.0101 *Apis mellifera.* a45 Api m 1 *Apis mellifera.* i209 Ves v 5.0101 *Vespula vulgaris.* a670 Ves v 5 *Vespula vulgaris.* i210 Pol d 5.0101 *Polistes dominulus.* i211 Ves v 1.0101 *Vespula vulgaris.* i213 Api m 4 *Apis mellifera.* i214 Api m 2 *Apis mellifera.* i215 Api m 3 *Apis mellifera.* i216 Api m 5 *Apis mellifera.* i217 Api m 10 *Apis mellifera.* i220 Bla g 1.0101 *Blattella germanica.* i221 Bla g 2.0101 *Blattella germanica.* i222 Bla g 5.0101 *Blattella germanica.* i223 Bla g 7 *Blattella germanica.* a46 Api m 2 *Apis mellifera.* Miscellaneous o1 Cotton, crude fibers *Gossypium* spp. o3 Cotton (treated) *Gossypium* spp. o70 Seminal fluid *Homo sapiens.* o71 *Staphylococcus aureus* *Staphylococcus aureus.* o72 *Pichia pastoris* crude extract customer specific *Pichia pastoris.* o72 Sperm-sediment *Homo sapiens.* o73 *Pichia pastoris* crude extr. vector customer specific *Pichia pastoris.* o74 *Pichia pastoris* with vector customer specific *Pichia pastoris.* o201 Tobacco leaf, tobacco dust *Nicotiana tabacum.* o202 Artemia salina, fish feed *Artemia salina.* o203 Tetramin, fish feed NA. o207 Daphnia, fish feed *Daphnia* spp. o211 Mealworm *Tenebrio molitor.* o212 Streptavidin *Streptomyces avidini.* o213 MBP (maltose binding protein) *Escherichia coli.* o214 CCD; MUXF3 from bromelain *Ananas comosus.* o72 Enterotoxin A (Sta a SEA) *Staphylococcus aureus.* o73 Enterotoxin B (Sta a SEB) *Staphylococcus aureus.* Parasites p1 Ascaris *Ascaris suum.* p2 Echinococcus *Echinococcus granulosus.* p3 Schistosoma *Schistosoma mansoni.* p4 Anisakis (Herring Worm) *Anisakis simplex* ( *Anisakis* spp.). p5 Toxocara canis *Toxocara canis.* p10 Ani s 3.0101 *Anisakis simplex* ( *Anisakis* spp.). p11 Ani s 1 *Anisakis simplex* ( *Anisakis* spp.). Occupational k4 Threshing dust NA. k5 Flax NA. k7 Hay Dust NA. k8 Hop

(hops)*Humulus lupulus.* k12 Grain mill dust NA. k14 Kapok NA. k20 Sheep's wool (treated)

(wool)*Ovis aries* ( *Ovis* spp.). k21 Sheep's wool (Untreated) *Ovis aries* ( *Ovis* spp.). k23 Straw Dust NA. k33 Oak NA. k70 Green coffee bean *Coffea* spp. k71 Castor bean *Ricinus communis.* k72 Ispaghula *Plantago psyllium/Plantago ovata.* k73 Silk waste NA. k74 Silk *Bombyx mori.* k75 Isocyanate TDI (Toluene diisocyanate) NA. k76 Isocyanate MDI (Diphenylmethane diisocyanate) NA. k77 Isocyanate HDI (Hexamethylen diisocyanate) NA. k78 Ethylene oxide NA. k79 Phthalic anhydride NA. k80 Formaldehyde/Formalin NA. k81 Ficus *Ficus benjamina* ( *Ficus* spp.). k83 Cotton seed *Gossypium hirsutum.* k84 Sunflower seed *Helianthus annuus.* k85 Chloramin T NA. k86 Trimellitic anhydride, TMA NA. k87 Asp o 21, alpha-amylase *Aspergillus oryzae.* k89 Orris root *Iris florentina.* k99 HSA (Human Serum Albumin) (Hom s HSA) *Homo sapiens.* k201 Car p 1, Papain *Carica papaya.* k202 Ana c 2, Bromelain *Ananas comosus.* k204 Maxatase *Bacillus licheniformis.* k205 Alcalase *Bacillus* spp. k206 Savinase, Protease 1 (Bac l Subtilisin) *Bacillus* spp. k208 Gal d 4, Lysozyme *Gallus domesticus* ( *Gallus gallus domesticus; Gallus* spp.). k209 Hexahydrophtalic anhydrid NA. k210 Maleic anhydride NA. k211 Methyltetrahydrophtalic anhydrid NA. k212 Abachi wood dust *Triplochiton scleroxylon.* k213 Pepsin (Sus s Pepsin) *Sus scrofa* ( *Sus scrofa domesticus; Sus* spp.). k213 TCPA NA. k214 Bougainvillea *Bougainvillea* spp. k225 Horse radish peroxidase (Arm r HRP) *Armoracia rusticana.* k226 Ascorbate oxidase (Cuc p ascorbate oxidase) *Cucurbita pepo.* k301 Flour dust *Triticum* spp. k501 Savinase customer specific Proprietary knowledge of customer. k502 Lipolase customer specific Proprietary knowledge of customer. k503 Termamyl customer specific Proprietary knowledge of customer. k504 Clazinase customer specific Proprietary knowledge of customer. 66. In § 866.5910, revise paragraph

(b)to read as follows: § 866.5910 Quality control material for cystic fibrosis nucleic acid assays.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document. PART 868—ANESTHESIOLOGY DEVICES 67. The authority citation for part 868 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 68. In § 868.1040, revise paragraph

(b)to read as follows: § 868.1040 Powered algesimeter.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. 69. In § 868.2385, revise paragraph

(b)to read as follows: § 868.2385 Nitrogen dioxide analyzer.

(b)*Classification.* Class II (special controls). The device, when it is a standalone nitrogen dioxide analyzer and not those that are components of nitric oxide delivery systems intended to monitor nitrogen dioxide levels during inhaled nitric oxide therapy, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.” See § 868.1(e) for the availability of this guidance document. 70. In § 868.2500, revise paragraph

(b)to read as follows: § 868.2500 Cutaneous oxygen

(PcO2)monitor.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen

(PcO2)Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document. 71. In § 868.2550, revise paragraph

(b)to read as follows: § 868.2550 Pneumotachometer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. 72. In § 868.5180, revise paragraph

(b)to read as follows: § 868.5180 Rocking bed.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. 73. In § 868.6250, revise paragraph

(b)to read as follows: § 868.6250 Portable air compressor.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. PART 870—CARDIOVASCULAR DEVICES 74. The authority citation for part 870 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 75. In § 870.1330, revise paragraph

(b)to read as follows: § 870.1330 Catheter guide wire.

(b)*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 76. In § 870.1390, revise paragraph

(b)to read as follows: § 870.1390 Trocar.

(b)*Classification.* Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 77. In § 870.1650, revise paragraph

(b)to read as follows: § 870.1650 Angiographic injector and syringe.

(b)*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 78. In § 870.1875, revise paragraph (b)(2) to read as follows: § 870.1875 Stethoscope.

(b)* * *

(2)*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 79. In § 870.2675, revise paragraph

(b)to read as follows: § 870.2675 Oscillometer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 80. In § 870.2770, revise paragraph

(b)to read as follows: § 870.2770 Impedance plethysmograph.

(b)*Classification.* Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 81. In § 870.4280, revise paragraph

(b)to read as follows: § 870.4280 Cardiopulmonary prebypass filter.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 82. In § 870.4290, revise paragraph

(b)to read as follows: § 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 83. In § 870.4340, revise paragraph

(b)to read as follows: § 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 84. In § 870.4400, revise paragraph

(b)to read as follows: § 870.4400 Cardiopulmonary bypass blood reservoir.

(b)*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 85. In § 870.4420, revise paragraph

(b)to read as follows: § 870.4420 Cardiopulmonary bypass cardiotomy return sucker.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. 86. In § 870.4430, revise paragraph

(b)to read as follows: § 870.4430 Cardiopulmonary bypass intracardiac suction control.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. PART 872—DENTAL DEVICES 87. The authority citation for part 872 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l,* 371. 88. In § 872.1720, revise paragraph

(b)to read as follows: § 872.1720 Pulp tester.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. 89. In § 872.3260, revise paragraph

(b)to read as follows: § 872.3260 Cavity varnish.

(b)*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. 90. In § 872.3300, revise paragraph

(b)to read as follows: § 872.3300 Hydrophilic resin coating for dentures.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. 91. In § 872.3540, revise paragraph (b)(2) introductory text to read as follows: § 872.3540 OTC denture cushion or pad.

(b)* * *

(2)Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's: 92. In § 872.3560, revise paragraph

(b)introductory text to read as follows: § 872.3560 OTC denture reliner.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's: 93. In § 872.3590, revise paragraph

(b)to read as follows: § 872.3590 Preformed plastic denture tooth.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. 94. In § 872.3600, revise paragraph

(b)introductory text to read as follows: § 872.3600 Partially fabricated denture kit.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's: 95. In § 872.3890, revise paragraph

(b)to read as follows: § 872.3890 Endodontic stabilizing splint.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. 96. In § 872.5550, revise paragraph (b)(2) to read as follows: § 872.5550 Teething ring.

(b)* * *

(2)Class II (special controls) if the teething ring contains a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. 97. In § 872.6770, revise paragraph

(b)to read as follows: § 872.6770 Cartridge syringe.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. PART 874—EAR, NOSE, AND THROAT DEVICES 98. The authority citation for part 874 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 99. In § 874.1090, revise paragraph

(b)to read as follows: § 874.1090 Auditory impedance tester.

(b)*Classification.* Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. 100. In § 874.1120, revise paragraph

(b)to read as follows: § 874.1120 Electronic noise generator for audiometric testing.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. 101. In § 874.1325, revise paragraph

(b)to read as follows: § 874.1325 Electroglottograph.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. 102. In § 874.3310, revise paragraph

(b)to read as follows: § 874.3310 Hearing aid calibrator and analysis system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. 103. In § 874.3320, revise paragraph

(b)to read as follows: § 874.3320 Group hearing aid or group auditory trainer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. 104. In § 874.3330, revise paragraph

(b)to read as follows: § 874.3330 Master hearing aid.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. 105. In § 874.3430, revise paragraph

(b)to read as follows: § 874.3430 Middle ear mold.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. 106. In § 874.3730, revise paragraph

(b)to read as follows: § 874.3730 Laryngeal prosthesis (Taub design).

(b)*Classification.* Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. PART 876—GASTROENTEROLOGY-UROLOGY DEVICES 107. The authority citation for part 876 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 108. In § 876.1500, revise paragraph (b)(1) to read as follows: § 876.1500 Endoscope and accessories.

(b)* * *

(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 109. In § 876.4020, revise paragraph

(b)to read as follows: § 876.4020 Fiberoptic light ureteral catheter.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 110. In § 876.4270, revise paragraph

(b)to read as follows: § 876.4270 Colostomy rod.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 111. In § 876.4400, revise paragraph

(b)to read as follows: § 876.4400 Hemorrhoidal ligator.

(b)*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 112. In § 876.4500, revise paragraph

(b)to read as follows: § 876.4500 Mechanical lithotriptor.

(b)*Classification.* Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 113. In § 876.4770, revise paragraph

(b)to read as follows: § 876.4770 Urethrotome.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 114. In § 876.5010, revise paragraph

(b)to read as follows: § 876.5010 Biliary catheter and accessories.

(b)*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 115. In § 876.5025, revise paragraph

(b)introductory text to read as follows: § 876.5025 Vibrator for climax control of premature ejaculation.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special controls for this device are: 116. In § 876.5160, revise the section heading and paragraph

(b)to read as follows: § 876.5160 Urological clamp.

(b)*Classification.* Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 117. In § 876.5365, revise paragraph

(b)to read as follows: § 876.5365 Esophageal dilator.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 118. In § 876.5520, revise paragraph (b)(1) to read as follows: § 876.5520 Urethral dilator.

(b)* * *

(1)Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 119. In § 876.5630, revise paragraph

(b)to read as follows: § 876.5630 Peritoneal dialysis system and accessories.

(b)*Classification.* Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis

(CAPD)belt; and a catheter stand that does not include weigh scales. 120. In § 876.5665, revise paragraph

(b)to read as follows: § 876.5665 Water purification system for hemodialysis.

(b)*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 121. In § 876.5895, revise paragraph

(b)to read as follows: § 876.5895 Ostomy irrigator.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. 122. In § 876.5980, revise paragraph (b)(1) to read as follows: § 876.5980 Gastrointestinal tube and accessories.

(b)* * *

(1)Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. PART 878—GENERAL AND PLASTIC SURGERY DEVICES 123. The authority citation for part 878 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 124. In § 878.4370, revise paragraph

(b)to read as follows: § 878.4370 Surgical drape and drape accessories.

(b)*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 125. In § 878.4495, revise paragraph

(b)to read as follows: § 878.4495 Stainless steel suture.

(b)*Classification.* Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document. 126. In § 878.4580, revise paragraph

(b)to read as follows: § 878.4580 Surgical lamp.

(b)*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 127. In § 878.5070, revise paragraph

(b)to read as follows: § 878.5070 Air-handling apparatus for a surgical operating room.

(b)*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES 128. The authority citation for part 880 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 129. In § 880.5580, revise paragraph

(b)introductory text to read as follows: § 880.5580 Acupuncture needle.

(b)*Classification.* Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls: 130. In § 880.5680, revise paragraph

(b)to read as follows: § 880.5680 Pediatric position holder.

(b)*Classification.* Class I (general controls). Except when the device is an infant positioner for prescription use in highly monitored settings or an infant sleep position holder, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. The device is exempt from the good manufacturing practice regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files. 131. In § 880.5780, revise paragraph (a)(2) to read as follows: § 880.5780 Medical support stocking.

(a)* * *

(2)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. 132. In § 880.6250, revise paragraph

(b)to read as follows: § 880.6250 Non-powdered patient examination glove.

(b)*Classification.* Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. 133. In § 880.6375, revise paragraph

(b)to read as follows: § 880.6375 Patient lubricant.

(b)*Classification.* Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. 134. In § 880.6760, revise paragraph

(b)to read as follows: § 880.6760 Protective restraint.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. PART 882—NEUROLOGICAL DEVICES 135. The authority citation for part 882 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 136. In § 882.1020, revise paragraph

(b)to read as follows: § 882.1020 Rigidity analyzer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. 137. In § 882.1030, revise paragraph

(b)to read as follows: § 882.1030 Ataxiagraph.

(b)*Classification.* Class I (general controls). Except when the device is intended to provide an interpretation or a clinical implication of the measurement, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. 138. In § 882.1470, revise paragraph

(b)introductory text to read as follows: § 882.1470 Computerized cognitive assessment aid.

(b)*Classification.* Class II (special controls). Except when the computerized cognitive assessment aid is intended for diagnostic assessment of specific diseases or conditions and relies on inputs from visual cues, auditory cues, and/or functional use of the hand, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special control(s) for this device are: 139. In § 882.1540, revise paragraph

(b)to read as follows: § 882.1540 Galvanic skin response measurement device.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. 140. In § 882.1560, revise paragraph

(b)to read as follows: § 882.1560 Skin potential measurement device.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. 141. In § 882.1855, revise paragraph

(b)to read as follows: § 882.1855 Electroencephalogram

(EEG)telemetry system.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. 142. In § 882.4060, revise paragraph

(b)to read as follows: § 882.4060 Ventricular cannula.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. 143. In § 882.4545, revise paragraph

(b)to read as follows: § 882.4545 Shunt system implantation instrument.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. 144. In § 882.5895, revise paragraph

(b)introductory text to read as follows: § 882.5895 Vibratory counter-stimulation device.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. The special controls for this device are: PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES 145. The authority citation for part 884 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 146. In § 884.1630, revise paragraph

(b)to read as follows: § 884.1630 Colposcope.

(b)*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 147. In § 884.2990, revise paragraph

(b)to read as follows: § 884.2990 Breast lesion documentation system.

(b)*Classification.* Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document. 148. In § 884.3200, revise paragraph

(b)to read as follows: § 884.3200 Cervical drain.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 149. In § 884.4400, revise paragraph

(b)to read as follows: § 884.4400 Obstetric forceps.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 150. In § 884.4530, revise paragraph (b)(1) to read as follows: § 884.4530 Obstetric-gynecologic specialized manual instrument.

(b)* * *

(1)Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 151. In § 884.4900, revise paragraph

(b)to read as follows: § 884.4900 Obstetric table and accessories.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 152. In § 884.5200, revise paragraph

(b)introductory text to read as follows: § 884.5200 Hemorrhoid prevention pressure wedge.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special controls for this device are: 153. In § 884.5390, revise paragraph

(b)to read as follows: § 884.5390 Perineal heater.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 154. In § 884.5400, revise paragraph

(b)to read as follows: § 884.5400 Menstrual cup.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 155. In § 884.5425, revise paragraph (b)(2) to read as follows: § 884.5425 Scented or scented deodorized menstrual pad.

(b)* * *

(2)Class II (special controls) for scented or scented deodorized menstrual pads made of materials not described in paragraph (b)(1). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 156. In § 884.5435, revise paragraph

(b)to read as follows: § 884.5435 Unscented menstrual pad.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9 only when the device is made of common cellulosic and synthetic material with an established safety profile. 157. In § 884.6120, revise paragraph

(b)to read as follows: § 884.6120 Assisted reproduction accessories.

(b)*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; or a controlled-rate cryopreservation freezer, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 158. In § 884.6130, revise paragraph

(b)to read as follows: § 884.6130 Assisted reproduction microtools.

(b)*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 159. In § 884.6150, revise paragraph

(b)to read as follows: § 884.6150 Assisted reproduction micromanipulators and microinjectors.

(b)*Classification.* Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. 160. In § 884.6160, revise paragraph

(b)to read as follows: § 884.6160 Assisted reproduction labware.

(b)*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. PART 886—OPHTHALMIC DEVICES 161. The authority citation for part 886 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 162. In § 886.1120, revise paragraph

(b)to read as follows: § 886.1120 Ophthalmic camera.

(b)*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 163. In § 886.1250, revise paragraph

(b)to read as follows: § 886.1250 Euthyscope.

(b)*Classification.*

(1)Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2)Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 164. In § 886.1570, revise paragraph

(b)to read as follows: § 886.1570 Ophthalmoscope.

(b)*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 165. In § 886.1780, revise paragraph (b)(1) to read as follows: § 886.1780 Retinoscope.

(b)* * *

(1)Class II (special controls) for the AC-powered device. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 166. In § 886.1850, revise paragraph

(b)to read as follows: § 886.1850 AC-powered slitlamp biomicroscope.

(b)*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 167. In § 886.1945, revise paragraph

(b)to read as follows: § 886.1945 Transilluminator.

(b)*Classification.*

(1)Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2)Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 168. In § 886.3320, revise paragraph

(b)to read as follows: § 886.3320 Eye sphere implant.

(b)*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 169. In § 886.4070, revise paragraph

(b)to read as follows: § 886.4070 Powered corneal burr.

(b)*Classification.* Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 170. In § 886.4150, revise paragraph

(b)to read as follows: § 886.4150 Vitreous aspiration and cutting instrument.

(b)*Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 171. In § 886.4250, revise paragraph

(b)to read as follows: § 886.4250 Ophthalmic electrolysis unit.

(b)*Classification.*

(1)Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2)Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 172. In § 886.4335, revise paragraph

(b)to read as follows: § 886.4335 Operating headlamp.

(b)*Classification.*

(1)Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2)Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 173. In § 886.4400, revise paragraph

(b)to read as follows: § 886.4400 Electronic metal locator.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 174. In § 886.4440, revise paragraph

(b)to read as follows: § 886.4440 AC-powered magnet.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. 175. In § 886.4790, revise paragraph

(b)to read as follows: § 886.4790 Ophthalmic sponge.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. PART 888—ORTHOPEDIC DEVICES 176. The authority citation for part 888 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 177. In § 888.1240, revise paragraph

(b)to read as follows: § 888.1240 AC-powered dynamometer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. 178. In § 888.4580, revise paragraph

(b)to read as follows: § 888.4580 Sonic surgical instrument and accessories/attachments.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. PART 890—PHYSICAL MEDICINE DEVICES 179. The authority citation for part 890 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 180. In § 890.1450, revise paragraph

(b)to read as follows: § 890.1450 Powered reflex hammer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. 181. In § 890.5100, revise paragraph

(b)to read as follows: § 890.5100 Immersion hydrobath.

(b)*Classification.* Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. 182. In § 890.5110, revise paragraph

(b)to read as follows: § 890.5110 Paraffin bath.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. 183. In § 890.5250, revise paragraph

(b)to read as follows: § 890.5250 Moist steam cabinet.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. 184. In § 890.5360, revise paragraph

(b)to read as follows: § 890.5360 Measuring exercise equipment.

(b)*Classification.* Class II (special controls). The device, when it is a measuring exerciser, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. 185. In § 890.5500, revise paragraph

(b)to read as follows: § 890.5500 Infrared lamp.

(b)*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. 186. In § 890.5575, revise paragraph

(b)to read as follows: § 890.5575 Powered external limb overload warning device.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. PART 892—RADIOLOGY DEVICES 187. The authority citation for part 892 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 *l* , 371. 188. In § 892.1000, revise paragraph

(b)to read as follows: § 892.1000 Magnetic resonance diagnostic device.

(b)*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 189. In § 892.1560, revise paragraph

(b)to read as follows: § 892.1560 Ultrasonic pulsed echo imaging system.

(b)*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 190. In § 892.1610, revise paragraph

(b)to read as follows: § 892.1610 Diagnostic x-ray beam-limiting device.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 191. In § 892.1650, revise paragraph

(b)to read as follows: § 892.1650 Image-intensified fluoroscopic x-ray system.

(b)*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph

(a)of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 192. In § 892.1670, revise paragraph

(b)to read as follows: § 892.1670 Spot-film device.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 193. In § 892.1680, revise paragraph

(b)to read as follows: § 892.1680 Stationary x-ray system.

(b)*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 194. In § 892.1730, revise paragraph

(b)to read as follows: § 892.1730 Photofluorographic x-ray system.

(b)*Classification.* Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 195. In § 892.1820, revise paragraph

(b)to read as follows: § 892.1820 Pneumoencephalographic chair.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 196. In § 892.1850, revise paragraph

(b)to read as follows: § 892.1850 Radiographic film cassette.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 197. In § 892.1860, revise paragraph

(b)to read as follows: § 892.1860 Radiographic film/cassette changer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 198. In § 892.1870, revise paragraph

(b)to read as follows: § 892.1870 Radiographic film/cassette changer programmer.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 199. In § 892.1900, revise paragraph

(b)to read as follows: § 892.1900 Automatic radiographic film processor.

(b)*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 200. In § 892.2030, revise paragraph

(b)to read as follows: § 892.2030 Medical image digitizer.

(b)*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group

(JPEG)Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 201. In § 892.2040, revise paragraph

(b)to read as follows: § 892.2040 Medical image hardcopy device.

(b)*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group

(JPEG)Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. 202. In § 892.5730, revise paragraph

(b)to read as follows: § 892.5730 Radionuclide brachytherapy source.

(b)*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. Dated: December 13, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019-27394 Filed 12-27-19; 8:45 am]

Rules and Regulations. Final amendment; final order