21 CFR 862.1650
§ 862.1650 Pyruvate kinase test system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 862.1650, § 862.1650 Pyruvate kinase test system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89178
- Permanent ID
ys:prov:89178@1- SHA-256
c71242c6f3afa5dea78518663a1824f2d0dab590a22c87a35d2a7586d8c02f16
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Full text
(a) 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.
(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 § 862.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.