# K060295: Carbon Dioxide

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 4, 2006 after 87 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K842280 (1984). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032377: Roche Diagnostics Hitachi Bicarbonate Liquid, Roche Diagnostics Corp. (2003) Summary page 2.

## Recalls of this device
- Oct 23, 2019 · Class II · Z-0575-2020: Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the Alinity c Carbon Dioxide reagent, resulting in the potential for incorrect results. Abbott was ma

## Indications for use
The Carbon Dioxide test system, reagent and calibrator, is a device intended to measure bicarbonate/carbon dioxide in plasma, and serum. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentiafly serious disorders associated with changes in body acid-base balance.

Source page: https://510kreport.com/device/K060295
Methodology: https://510kreport.com/methodology