JWR · Atp Release (Luminescence)
Hematology · 21 CFR 864.7040 · Class 1
Overview
| Product Code | JWR |
|---|---|
| Device Name | Atp Release (Luminescence) |
| Regulation | 21 CFR 864.7040 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
