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SAN DIEGO, CA - 30 December 2025 - Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearances to market the Diazyme Colorimetric Lithium Assay.

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 patients suffering from bipolar disorder and to avoid toxicity. With this new assay, Diazyme reinforces its commitment to improving patient outcomes through advanced clinical diagnostics.

By Dr. Yuqi Huang, Assay Development Scientist at Diazyme Laboratories

Lithium carbonate has long stood as one of the most effective treatments for managing bipolar disorder, particularly manic-depressive psychosis. However, despite its therapeutic success, lithium’s narrow therapeutic index poses a significant risk—small deviations in dosage can lead to acute lithium toxicity. This makes precise and timely monitoring of serum lithium levels essential for patient safety.

Recognizing this critical clinical need, Dr. Yuqi Huang and the research team at Diazyme Laboratories have developed and validated an improved colorimetric lithium assay with enhanced performance and on-board stability. This innovation marks a significant step forward in clinical lithium monitoring, offering laboratories a cost-effective, easy-to-use, and highly accurate solution.

“Diazyme has devoted to developing innovative lithium assays with its proprietary enzyme technology. Diazyme developed the first and the only enzymatic lithium assay years ago, and today we received FDA’s 510K clearance for the improved colorimetric lithium assay with enhanced analytic performances.  The new colorimetric lithium assay offers a prolonged reagent on-board stability and calibration frequency that has been extended from one day to one week in comparison with other commercially available lithium assays. This improvement in reagent stability significantly enhances the test accuracy and reduces the test cost as well as lab workload by avoiding the need of daily calibrations”, said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc. 

Validated Performance on Widely Used Chemistry Analyzers

The assay was developed and validated on both the Roche Cobas c701 and the Beckman Coulter AU680 chemistry analyzers, demonstrating:

• Measuring range: 0.10 mmol/L – 3.00 mmol/L
• Limit of Quantification (LOQ): 0.10 mmol/L
• No interference from common serum components
• Improved reagent stability with the addition of a pH stabilizer

About Diazyme

Diazyme Laboratories, Inc. is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic test reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme's technology and products can be found on its website at www.diazyme.com

For Further Information Contact:

Regulatory
Dr. Abhijit Datta, Ph.D
Abhijit.Datta@diazyme.com

Sales
Emile Dergham
610-694-0435
Emile.Dergham@Diazyme.com