# K060619: Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122A

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Jul 21, 2006 after 135 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 K990754 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990754: Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50, Diagnostic Chemicals, Ltd. (1999) Summary page 1.

## Indications for use
Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO 2) in serum and plasma. Diazyme Carbon Dioxide Enzymatic Assay Kit contains a single-point calibrator. The calibrator, along with 0.9% saline as a zero reference, is used to generate a linear graph that will be used in the calculation of carbon dioxide concentrations in unknown samples. Diazyme Carbon Dioxide Control Set has controls for normal carbon dioxide level and abnormal carbon dioxide level. The controls are used as reference samples for checking the functionality of the Diazyme Carbon Dioxide Enzymatic Assay.

Source page: https://510kreport.com/device/K060619
Methodology: https://510kreport.com/methodology