# K073223: S-Test C02

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
- Decided: Jun 26, 2008 after 224 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 K931786 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931786: Ace Clinical Chemistry  System, Schiapparelli Biosystems, Inc. (1993) Summary page 1.
- K946090: Kodak Ektacchem 950IRC Analyzer, Clinical Diagnostic Systems, Inc. (1995) Summary page 1.
- K942782: Piccolo (TM), Abaxis, Inc. (1995) Summary page 1.

## Indications for use
The S-Test Carbon Dioxide Reagent is intended for the quantitative determination of carbon dioxide concentration in serum or heparin plasma using the S40 Clinical Analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K073223
Methodology: https://510kreport.com/methodology