# K113269: Elittech Clinical Systems Alp Ifcc SL

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Dec 29, 2011 after 55 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- 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 K895880 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033185: Cobas Integra Alp Ifcc Gen.2, Roche Diagnostics Corp. (2003) Summary page 1.

## Indications for use
ELiTech Clinical Systems ALP IFCC SL is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma on ELiTech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Alkaline phosphatase or its isoienzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.

Source page: https://510kreport.com/device/K113269
Methodology: https://510kreport.com/methodology