DiazYme Lithium Enzymatic Assay Kit

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K033360 ↗

FDA Product Code

JII

Device Class

Class II

Regulation

21 CFR Part 862.3560

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the DiazYme Lithium Enzymatic Assay Kit used for?

  The DiazYme Lithium Enzymatic Assay Kit is used for the quantitative determination of lithium in serum or plasma samples. It is an enzymatic assay designed for in vitro diagnostic use in clinical laboratories to measure lithium concentrations, supporting patient monitoring and therapeutic drug management.

• How is the DiazYme Lithium Enzymatic Assay Kit supplied and is it sterile or single-use?

  The kit is supplied as a reagent system for clinical laboratory use and is provided in a non-sterile format. It is intended for single-use testing only, meaning each test should be performed with a fresh kit or reagent set to ensure accurate and reliable results, and it is not designed for reuse.

• What regulatory pathway was used for the DiazYme Lithium Enzymatic Assay Kit and what is its classification?

  The DiazYme Lithium Enzymatic Assay Kit received FDA 510(k) clearance under submission K033360 and is classified as a Class II medical device. It is regulated under product code JII and falls within the Clinical Toxicology specialty, indicating its use in measuring substances like lithium for diagnostic purposes.