# K111915: Magnesium Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sekisui Diagnostics P.E.I., Inc.
- Decided: Dec 2, 2011 after 149 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 K944407 (1994). 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)
- K944407: Olympus Magnesium Reagent, Olympus America, Inc. (1994) Summary page 2.

## Indications for use
The Sekisui Magnesium Assay is intended for the quantitative measurement of magnesium in human serum and plasma (Lithium Heparin) on automated clinical chemistry analyzers. Magnesium measurements are used in the diagnosis and treatment of hypomnagnesemia and hypermagnesemia. This device is intended for professional use and IN VITRO diagnostic use only.

Source page: https://510kreport.com/device/K111915
Methodology: https://510kreport.com/methodology