# K243462: Diazyme Colorimetric Lithium Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories, Inc.
- Decided: Aug 1, 2025 after 266 days
- Product code: NDW (Assay, Porphyrin, Spectrophotometry, 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
Diazyme Colorimetric Lithium Assay kit is for quantitative in vitro determination of lithium in human serum or EDTA plasma. Measurements of lithium are carried out 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/K243462
Methodology: https://510kreport.com/methodology