# K981791: MG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 23, 1998 after 155 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 K811194 (1981). 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)
- K811194: Hitachi 705 Automatic Blood Chemistry, Boehringer Mannheim Corp. (1981) Summary page 1.

## Recalls of this device
- Jan 2, 2019 · Class II · Z-0971-2019: Abbott internal testing has identified that the Magnesium urine application demonstrates depressed urine result recovery. All samples >0.5mEq/L fail the linearity acceptance criteria for the bias spec

## Indications for use
The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine. 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).

Source page: https://510kreport.com/device/K981791
Methodology: https://510kreport.com/methodology