# K173294: Magnesium

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 18, 2018 after 214 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
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. The FDA summary names its predicate without a number.
- (no number) Roche Magnesium Gen.2: named in the summary without a submission number

## Indications for use
The Magnesium assay is used for the quantitation of magnesium in human serum or plasma on the ARCHITECT c8000 System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Source page: https://510kreport.com/device/K173294
Methodology: https://510kreport.com/methodology