# K990434: Careside CKMB

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Apr 19, 1999 after 67 days
- Product code: JHS (Differential Rate Kinetic 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
Longest line of descent: 1 generation back to K912844 (1991). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure CK-MB from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myopathic disorders including myocardial infarction, myocarditis, Duchenne’s muscular dystrophy, polymyosititis, and rhabdomyolysis.

Source page: https://510kreport.com/device/K990434
Methodology: https://510kreport.com/methodology