# K031879: Cobas Integra Carbon Dioxide Assay

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 17, 2003 after 29 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- 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 K842280 (1984). 6 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980996: Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf), Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K032377: Roche Diagnostics Hitachi Bicarbonate Liquid (2003), 2 descendants of its own
- K183555: GEM Premier ChemSTAT (2019), 1 descendant of its own
- K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer (2006), 1 descendant of its own
- K223090: GEM Premier ChemSTAT (2023), 0 descendants of its own
- K111960: Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators (2011), 0 descendants of its own

## Indications for use
The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3-) concentration in human serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K031879
Methodology: https://510kreport.com/methodology