21 CFR § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system.

---
identifier: "/us/cfr/t21/s862.1215"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1215"
section_name: "Creatine phosphokinase/creatine kinase or isoenzymes test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 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.