# K043267: Potassium Test Kit and Electrolyte Cal 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Feb 10, 2005 after 76 days
- Product code: CEJ (Tetraphenyl Borate, Colorimetry, Potassium)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Randox Laboratories Ltd. Potassium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Potassium in serum. Potassium is determined enzymatically via Potassium dependant pyruvate kinase activity using phosphoenolpyruvate as substrate. The pyruvate formed reacts with NADH in the presence of LDH to form lactate and NAD. The corresponding decrease in absorbance at 340 nm is proportional to the potassium concentration Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. This Application Sheet has been developed for the Hitachi 704, 717, 902 and 911/912 Analysers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions. Randox Electrolyte Cal 1 and 2 Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA+, K+ and CL- electrodes on Hitachi systems ISE modules and Randox Enzymatic Potassium kit. The Randox Electrolyte Cal 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K043267
Methodology: https://510kreport.com/methodology