# K132571: Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 18, 2013 after 64 days
- Product code: JHY (Colorimetric 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: 4 generations back to K931172 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022654: Modification to Elecsys CK-MB Stat, Elecsys CK-MB, Roche Diagnostics Corp. (2002) Summary page 1.

## Most influential descendants
- K140404: Elecsys CK-MB Stat Immunoassay (2014), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K132571
Methodology: https://510kreport.com/methodology