# K040115: Piccolo Magnesium Test System

- Pathway: 510(k) (Traditional)
- Applicant: Abaxis, Inc.
- Decided: Jan 30, 2004 after 10 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 K861386 (1986). 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)
- K861386: Kodak Ektachem Clinical Chemistry Slides (MG), Eastman Kodak Company (1986) Summary page 1.

## Indications for use
Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia and hypermagnesemia.

Source page: https://510kreport.com/device/K040115
Methodology: https://510kreport.com/methodology