# K100289: Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: May 10, 2010 after 97 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: 1 generation back to K042362 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042362: Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12, Diagnostic Chemicals, Ltd. (2004) Summary page 1.

## Most influential descendants
- K152085: Liquid CO2-2 (LCO2-2) (2016), 0 descendants of its own

## Indications for use
For in vitro diagnostic use in the quantitative determination of carbon dioxide in human serum and plasma on ADVIA Chemistry Systems. Such 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/K100289
Methodology: https://510kreport.com/methodology