# K111960: Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Nov 18, 2011 after 130 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: 4 generations back to K842280 (1984). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031879: Cobas Integra Carbon Dioxide Assay, Roche Diagnostics Corp. (2003) Summary page 1.
- (no number) Roche Diagnostics, Ammonia/Ethanol/CO2 calibrator: named in the summary without a submission number

## Indications for use
The carbon dioxide electrode for the ELiTech Clinical Systems Selectra ProM is intended for use for the quantitative in vitro diagnostic determination of Total CO2 in human serum and plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. ELiTech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), chloride (Cl-) and carbon dioxide (Total CO2) on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module.

Source page: https://510kreport.com/device/K111960
Methodology: https://510kreport.com/methodology