# K162526: Creatine Kinase-MB

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 26, 2017 after 259 days
- Product code: JHW (U.V. Method, Cpk 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 K003158 (2000). 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)
- K003158: Roche Diagnostics CK-MB, Roche Diagnostics Corp. (2000) Summary page 5.

## Indications for use
The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems. 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/K162526
Methodology: https://510kreport.com/methodology