# K981897: Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Aug 26, 1998 after 86 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: 1 generation back to K895880 (1989). 2 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 2.
- K895880: Pancreatic a-Amylase Eps, Boehringer Mannheim Corp. (1989) Summary page 2.

## Most influential descendants
- K003400: CRP HS Test System (2001), 12 descendants of its own
- K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) (2004), 7 descendants of its own
- K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set (2011), 3 descendants of its own
- K033185: Cobas Integra Alp Ifcc Gen.2 (2003), 3 descendants of its own
- K032336: Tina-Quant CRP (Latex) (2003), 3 descendants of its own

## Indications for use
The cassette COBAS INTEGRA Alkaline Phosphatase IFCC liquid (ALPL2 and ALPL6) contain an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. The cassette COBAS INTEGRA a-Amylase EPS Pancreatic (AMY-P / AMYUP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of pancreatic a-amylase in serum, plasma, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). The cassette C-reactive Protein (Latex), (CRPLX) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human C-reactive protein in serum and plasma.

Source page: https://510kreport.com/device/K981897
Methodology: https://510kreport.com/methodology