# K141265: Elitech Clinical Systems Envoy 500 CK Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Jul 18, 2014 after 64 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: 5 generations back to K781921 (1979). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122083: Elitech Clinical Systems CK Nac SL, Elitechgroup (2012) Summary page 1.

## Indications for use
ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of crestine kinase (CK) in human serum and plasma using the ENVOY 500 Chemistry System. It is not intended for use in Point of Care settings. Creatine phosphokinase and its iscozymes measurements 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/K141265
Methodology: https://510kreport.com/methodology