# K980012: Creatine Kinase Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Ac Biochemicals, Inc.
- Decided: Feb 25, 1998 after 54 days
- Product code: JHX (Fluorometric Method, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.

Source page: https://510kreport.com/device/K980012
Methodology: https://510kreport.com/methodology