# K042189: Diazyme Sodium Enzymatic Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Oct 7, 2004 after 56 days
- Product code: MZU (System, Test, Sodium, Enzymatic Method)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011213 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023049: Synchron LX I 725 Clinical System, Beckman Coulter, Inc. (2002) Summary page 1.

## Indications for use
Diazyme Sodium Enzymatic Assay Kit in conjunction with Diazyme Sodium Low and High Calibrators, are intended for the quantitative determination of sodium (NA) in serum. Diazyme Sodium Enzymatic Assay Kit contains a low level standard and a high level standard. The standards are used to generate a linear graph that will be used in the calculation of sodium concentrations in unknown serum samples. Diazyme Sodium Enzymatic Assay has controls for normal serum sodium level and abnormal serum sodium level. The controls are used as reference samples for checking the functionality of the Diazyme Sodium Enzymatic Assay.

Source page: https://510kreport.com/device/K042189
Methodology: https://510kreport.com/methodology