# K050338: Modification to: Instaread Lithium System

- Pathway: 510(k) (Special)
- Applicant: Akers Biosciences, Inc.
- Decided: Mar 4, 2005 after 21 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The InstaReadTM Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). 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).

Source page: https://510kreport.com/device/K050338
Methodology: https://510kreport.com/methodology