§ 862.3280. Clinical toxicology control material.
102 words·~1 min read·
/us/cfr/t21/s§ 862.3280·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
(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. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000, 84 FR 71798, Dec. 30, 2019]