# K081193: Cobas Integra 400/800 Bilirubin Total

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Jan 16, 2009 after 263 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- 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 K951595 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
In vitro test for the quantitative determination of the total bilirubin concentration in human serum on COBAS Integra systems Measurement of the level of bilrubm is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block

Source page: https://510kreport.com/device/K081193
Methodology: https://510kreport.com/methodology