# K981218: Creatine Kinase (CK)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 1, 1998 after 28 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K834502 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834502: CK-Nac Reagent, Roche Diagnostic Systems, Inc. (1984) Summary page 2.

## Indications for use
The Creatine Kinase assay is used for the quantitation of creatine kinase in human 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.

Source page: https://510kreport.com/device/K981218
Methodology: https://510kreport.com/methodology