---
kind: "section"
citation: "21 C.F.R. § 864.7040"
title: "21"
number: "864.7040"
heading: "Adenosine triphosphate release assay."
url: "https://uscodex.org/cfr/21/864.7040"
---

# §864.7040. Adenosine triphosphate release assay.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60609, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[45 FR 60609, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]