# K040975: Genchem CO2 Acid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Genchem, Inc.
- Decided: Dec 27, 2004 after 257 days
- Product code: JFL (Ph Rate Measurement, 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 K883181 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014034: Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro), Beckman Coulter, Inc. (2001) Summary page 1.

## Indications for use
The GenChem CO 2 Acid Reagent when used in conjunction with the GenChem ISE Electrolyte Reference, GenChem Electrolyte Buffer, GenChem C02 Alkaline Buffer, GenChem Wash Concentrate, and appropriate Calibrators or Calibration Standards is intended for the quantitative determination of Carbon Dioxide in serum and plasma on the Beckman CX3®. Carbon Dioxide results are used in the diagnosis and treatment of numerous and potentially serious disorders associated with changes in the body's acid-base balance.

Source page: https://510kreport.com/device/K040975
Methodology: https://510kreport.com/methodology