# K162200: Randox RX Daytona Plus Magnesium (MG)

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Apr 28, 2017 after 266 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
Longest line of descent: 1 generation back to K991576 (1999). 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)
- K991576: Additional Assays for the Bayer Advia 1650 Chemistry System, Bayer Corp. (1999) Summary page 5.

## Recalls of this device
- Nov 13, 2020 · Class II · Z-0547-2021: 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 RX daytona plus magnesium (Mg) test system is intended for use in the quantitative determination of magnesium concentration in lithium heparinized plasma, serum and urine. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

Source page: https://510kreport.com/device/K162200
Methodology: https://510kreport.com/methodology