# K990754: Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Apr 20, 1999 after 43 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060619: Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122A (2006), 0 descendants of its own

## Indications for use
For the quantitative determination of carbon dioxide in serum. For IN VITRO diagnostic use. Elevated blood CO₂ is almost synonymous with respiratory acidosis. The latter is restricted to clinical conditions with a primary increase in carbon dioxide in the inspired air or increased metabolic production of carbon dioxide. Decreased blood CO₂ is almost synonymous with respiratory alkalosis. The latter is restricted to clinical conditions with a primary decrease in carbon dioxide which can result from increased pulmonary ventilation due to mechanical ventilation or stimulation of the respiratory center (1). Classic techniques for the measurement of carbon dioxide (CO₂) involve the addition of acid to liberate the carbon dioxide and the measurement of carbon dioxide thus released by either manometric, volumetric, or titrimetric techniques. These procedures are both time consuming and cumbersome. The DCL Carbon Dioxide-L3K assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NAD analog (3), which is easy to use and applicable to routine laboratory instrumentation.

Source page: https://510kreport.com/device/K990754
Methodology: https://510kreport.com/methodology