# K181748: Magnesium

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 12, 2018 after 72 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 K810084 (1981). 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)
- K983416: Roche Diagnostics Magnesium Reagent, Cat# 1551353, Boehringer Mannheim Corp. (1998) Summary page 4.

## Indications for use
The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine 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/K181748
Methodology: https://510kreport.com/methodology