# K042362: Modification to Carbon Dioxide-L3K Assay, Cat. Nos. 299-30, 299-17, 299-50, 299-80 and 299-12

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Dec 27, 2004 after 118 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K100289: Advia Chemistry Systems Carbon Dioxide Liquid (C02_L) Assay, Model Ref 07987100, 07506781 (2010), 1 descendant of its own
- K152085: Liquid CO2-2 (LCO2-2) (2016), 0 descendants of its own
- K140248: S Test Reagent Cartridge Carbon Dioxide (CO2) (2014), 0 descendants of its own

## Indications for use
For the quantitative determination of carbon dioxide in serum and plasma. For INVITRO diagnostic use. Elevated blood CO 2 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 CO 2 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 NADH analog (3), which is easy to use and applicable to routine laboratory instrumentation.

Source page: https://510kreport.com/device/K042362
Methodology: https://510kreport.com/methodology