# K013912: Creatine Kinase (CK-Nac)

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: Jan 18, 2002 after 52 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Diagnostics CK NAC Reagent for the Roche Cobas Mira analyzers: named in the summary without a submission number
- (no number) Pointe Scientific Creatine Kinase (CK) Reagent (generic): named in the summary without a submission number

## Indications for use
Intended for the In Vitro, quantitative determination of creatine kinase (CK) in human serum on automated chemistry analyzers. Creatine kinase measurements 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/K013912
Methodology: https://510kreport.com/methodology