# K033360: Diazyme Lithium Enzymatic Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: General Atomics
- Decided: Dec 23, 2003 after 63 days
- Product code: JII (Atomic Absorption, 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 K003583 (2001). 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)
- K003583: Lithium Regent Model TR66056 / Lithium Standard TR66901, Trace America, Inc. (2001) Summary page 1.

## Indications for use
Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of lithium in human serum. Measurements of lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.

Source page: https://510kreport.com/device/K033360
Methodology: https://510kreport.com/methodology