JNJ · Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase
Clinical Chemistry · 21 CFR 862.1650 · Class 1
Overview
| Product Code | JNJ |
|---|---|
| Device Name | Phosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase |
| Regulation | 21 CFR 862.1650 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells). Measurements obtained by this device are used in the diagnosis and treatment of various inherited anemias due to pyruvate kinase deficiency or of acute leukemias.
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 § 862.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
