# K122083: Elitech Clinical Systems CK Nac SL

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Aug 22, 2012 after 37 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: 4 generations back to K781921 (1979). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063744: Cobas Integra C 111, Rochdiag (2007) Summary page 1.
- K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 1.
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (2004) Summary page 1.

## Most influential descendants
- K141265: Elitech Clinical Systems Envoy 500 CK Reagent Kit (2014), 0 descendants of its own

## Indications for use
ELiTech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (OK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELiTech Clinical Systems on ELITech Clinical Systems Selectra analyzers. ELiTech Clinical Systems ELITROL I & ELITROL 11are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra analyzers.

Source page: https://510kreport.com/device/K122083
Methodology: https://510kreport.com/methodology