Regulations last checked for updates: May 07, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a) Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360l,371
source: 52 FR 16122, May 1, 1987, unless otherwise noted.
cite as: 21 CFR 862.1215