{"data":{"id":"us/21-cfr-864.7040","jurisdiction":"us","citation":"21 CFR 864.7040","heading":"Adenosine triphosphate release assay.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart H—Hematology Kits and Packages"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"4ef4d8875354a96d90d5fb76289599bb542802018b983d2086ec50785e8d3b6b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.7010","next":"us/21-cfr-864.7060"},"notice":"GroundRules: Original legal text. Not legal advice."}