# K230890: ISE Electrodes

- Pathway: 510(k) (Special)
- Applicant: Randox Laboratories, Ltd.
- Decided: Sep 8, 2023 after 161 days
- Product code: CEM (Electrode, Ion Specific, 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
Longest line of descent: 1 generation back to K052914 (2006). 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)
- K052914: RX Imola, Randox Laboratories, Ltd. (2006) Summary page 4.

## Indications for use
The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K230890
Methodology: https://510kreport.com/methodology