# K111996: Elitech Clinical Sysems Ise Control 1 and 2

- Pathway: 510(k) (Abbreviated)
- Applicant: Elitechgroup
- Decided: Sep 14, 2011 after 63 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K874280 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040273: Lyphochek Assayed Chemistry Control, Bio-Rad Laboratories, Inc. (2004) Summary page 1.

## Indications for use
ELITech Clinical Systems ISE CONTROL I and ISE CONTROL II are control sera for in vitro diagnostic use in quality control of ELITech Clinical Systems ISE Na, K, Cl, Total CO2 on ELITech Clinical Systems Selectra analyzers equipped with ISE Module.

Source page: https://510kreport.com/device/K111996
Methodology: https://510kreport.com/methodology