# K030010: Atac Pak Magnesium Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Elan Diagnostics
- Decided: Mar 10, 2003 after 67 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) Beckman Synchron Magnesium Reagent, product 445360: named in the summary without a submission number

## Indications for use
The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K030010
Methodology: https://510kreport.com/methodology