# K122302: Ace Magnesium Regent

- Pathway: 510(k) (Special)
- Applicant: Alfa Wassermann Diagnostics Technologies, LLC
- Decided: Aug 27, 2012 after 26 days
- Product code: JGJ (Photometric Method, Magnesium)
- Device class: 1
- Regulation: 21 CFR 862.1495
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931786 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113435: Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total Bilirubin Reagent, Ace Magnesium Reagent, Alfa Wassermann (2012)

## Indications for use
The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K122302
Methodology: https://510kreport.com/methodology