# K974606: Randox Magnesium

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Feb 12, 1998 after 64 days
- Product code: JGJ (Photometric Method, Magnesium)
- Device class: 1
- Regulation: 21 CFR 862.1495
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 13, 2020 · Class II · Z-0546-2021: Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

## Indications for use
The Randox Laboratories Limited Magnesium Test Kit is an in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium. Abnormal concentrations of magnesium (elevated or low) are associated with a variety of clinical conditions. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K974606
Methodology: https://510kreport.com/methodology