# K961501: Elecsys CK-MB

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jun 11, 1996 after 54 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 K931172 (1993). 1 ancestor in all.
57 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931172: Imx (R) Stat CK-MB, Abbott Laboratories (1993) Summary page 1.

## Most influential descendants
- K962575: Elecsys Precicontrol Cardiac (1996), 52 descendants of its own
- K983492: Boehringer Mannheim Elecsys Presicontrol Cardiac (1998), 51 descendants of its own
- K032089: Roche Diagnostics Elecsys Precicontrol Cardiac (2003), 41 descendants of its own
- K072437: Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset (2008), 20 descendants of its own
- K033937: Elecsys Precicontrol Multianalyte (2004), 19 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/K961501
Methodology: https://510kreport.com/methodology