# K983416: Roche Diagnostics Magnesium Reagent, Cat# 1551353

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 21, 1998 after 22 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: 1 generation back to K810084 (1981). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810084: Magnesium Kit, Bio-Analytics Laboratories, Inc. (1981) Summary page 1.

## Most influential descendants
- K181748: Magnesium (2018), 0 descendants of its own

## Indications for use
The Roche Diagnostics Magnesium reagent is intended for use for the quantitative determination of magnesium in human serum, plasma, and urine on automated clinical chemistry analyzers. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1495, a Magnesium test system is a device intended to measure magnesium levels in serum and plasma. 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). It is classified in Class L.

Source page: https://510kreport.com/device/K983416
Methodology: https://510kreport.com/methodology