§ 864.7040. Adenosine triphosphate release assay.
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/us/cfr/t21/s§ 864.7040·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An adenosine triphosphate release assay is a device that measures the release of adenosine triphosphate
(ATP)from platelets following aggregation. This measurement is made on platelet-rich plasma using a photometer and a luminescent firefly extract. Simultaneous measurements of platelet aggregation and ATP release are used to evaluate platelet function disorders.
(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. [45 FR 60609, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]