21 CFR § 864.7040 - Adenosine triphosphate release assay.

---
identifier: "/us/cfr/t21/s864.7040"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.7040 - Adenosine triphosphate release assay."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.7040"
section_name: "Adenosine triphosphate release assay."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 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 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]