# K171080: ALP IFCC Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: May 10, 2017 after 29 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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 5.

## Most influential descendants
- K191245: Yumizen C1200 ALP, Yumizen C1200 Albumin (2019), 0 descendants of its own

## Indications for use
ALP IFCC Gen.2 is an in vitro test intended for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma on COBAS INTEGRA systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Source page: https://510kreport.com/device/K171080
Methodology: https://510kreport.com/methodology