21 CFR 864.7040 — Atp Release (Luminescence)
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7040
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JWR | Atp Release (Luminescence) | 1 | 0 | |
| KHF | Adenine Nucleotide Quantitation | 1 | 0 |
