# K033185: Cobas Integra Alp Ifcc Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Oct 14, 2003 after 13 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: 2 generations back to K895880 (1989). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981897: Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae, Roche Diagnostic Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K171080: ALP IFCC Gen.2 (2017), 1 descendant of its own
- K191245: Yumizen C1200 ALP, Yumizen C1200 Albumin (2019), 0 descendants of its own
- K113269: Elittech Clinical Systems Alp Ifcc SL (2011), 0 descendants of its own

## Indications for use
The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contain an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. 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/K033185
Methodology: https://510kreport.com/methodology