# K990439: Careside CK

- 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 quantitatively measure CK from anti-coagulated whole blood, plasma, or serum specimens to aid in the diagnosis and treatment of patients with myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Source page: https://510kreport.com/device/K990439
Methodology: https://510kreport.com/methodology