# K122858: Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical Systems Elitrol I and Elitrol II

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Oct 3, 2012 after 15 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- 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.
No later device cites it as a predicate yet.
0 of 11 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.

## Indications for use
ELiTech Clinical Systems AMYLASE SL is intended for the quantitative in vitro determination of amylase in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). 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 11 are 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/K122858
Methodology: https://510kreport.com/methodology