21 CFR 864.7040

§ 864.7040 Adenosine triphosphate release assay.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 864.7040, § 864.7040 Adenosine triphosphate release assay, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89360
Permanent ID: ys:prov:89360@1
SHA-256: 38b549347e34da2ec95058007f9aa46664b0916c4775ec727fbe8a501386fe4b

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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.