# K031579: Instaread Lithium System

- Pathway: 510(k) (Traditional)
- Applicant: Akers Laboratories, Inc.
- Decided: Dec 19, 2003 after 213 days
- Product code: JIH (Flame Photometry, Lithium)
- Device class: 2
- Regulation: 21 CFR 862.3560
- 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 K934106 (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)
- K934106: Kodak Ektachem DTSC II Slides (LI), Eastman Kodak Company (1994) Summary page 1.

## Indications for use
The InstaReadTM Lithium System is intended to measure lithium blood levels. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). The test is targeted for physician's office use, and may be used with whole blood, serum, or EDTA-plasma.

Source page: https://510kreport.com/device/K031579
Methodology: https://510kreport.com/methodology