# K980996: Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Jun 5, 1998 after 80 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: 2 generations back to K842280 (1984). 5 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K954992: Roche Cobas Integra Reagent Cassettes, Roche Diagnostic Systems, Inc. (1996) Summary page 3.
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents, Roche Diagnostic Systems, Inc. (1997) Summary page 3.

## Most influential descendants
- K031879: Cobas Integra Carbon Dioxide Assay (2003), 8 descendants of its own
- 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

## Indications for use
The cassette Roche COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma. Determination of carbon dioxide concentration in blood is most commonly performed as an initial test in the evaluation of the body's ability to control blood pH by appropriate removal of metabolism byproducts via the lung and kidneys. The cassette Roche COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma, urine and cerebrospinal fluid (CSF). In addition, an optional glucose “fast application” for serum and plasma is available. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.

Source page: https://510kreport.com/device/K980996
Methodology: https://510kreport.com/methodology