# K130765: Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol II

- Pathway: 510(k) (Abbreviated)
- Applicant: Elitechgroup
- Decided: Apr 4, 2013 after 15 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K811832 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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 ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELiech Clinical Systems methods 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 ELiech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

Source page: https://510kreport.com/device/K130765
Methodology: https://510kreport.com/methodology