# K974421: Elecsys CK-MB Stat

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 17, 1997 after 23 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: 2 generations back to K931172 (1993). 2 ancestors in all.
3 later devices descend 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)
- K961501: Elecsys CK-MB, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K022654: Modification to Elecsys CK-MB Stat, Elecsys CK-MB (2002), 2 descendants of its own
- K132571: Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB Immunoassay (2013), 1 descendant of its own
- 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 (CK-MB) in human serum and plasma. A creatine phosphokinase / creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine kinase 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/K974421
Methodology: https://510kreport.com/methodology