# K053566: Modification to: Diazyme Potassium Enzymatic Assay, Model DZ113A

- Pathway: 510(k) (Special)
- Applicant: Diazyme Laboratories
- Decided: Feb 15, 2006 after 55 days
- Product code: MZV (Test, System, Potassium, Enzymatic Method)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of potassium in human serum. Measurements obtained by this assay are used to monitor electrolyte balance. Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. The controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.

Source page: https://510kreport.com/device/K053566
Methodology: https://510kreport.com/methodology