FDA Grants Diazyme 510(k) Clearance to Market Its 1,5 AG Assay for Clinical Chemistry Analyzers

FDA Grants Diazyme 510(k) Clearance to Market Its 1,5 AG Assay for Clinical Chemistry Analyzers

SAN DIEGO, CA – 5 November 2018 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its 1,5 AG assay. Diazyme's 1,5 AG assay provides a fully automated two reagent assay for use on validated clinical chemistry analyzers.

"Diazyme's 1,5-AG assay is a universal fully automated test that is specifically designed for use on clinical chemistry analyzers. This liquid stable, ready-to-use two reagent system is for the intermediate term monitoring of glycemic control in people with diabetes.

This assay enables clinical laboratories of almost any size to run this test in house without the need for expensive specialized instrumentation. With no sample pre-treatment or pre-dilution steps required, this assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods." said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.

Diazyme Laboratories, Inc. is an affiliate of General Atomics, headquartered in La Jolla, California. Diazyme uses its unique platform technologies to develop innovative assays for clinical and research uses with reduced costs and improved performance. Products include diagnostic blood tests for cardiac markers, diabetes, vitamins and nutritional assessments, liver disease, renal disease and electrolytes. Information regarding Diazyme's technologies and related 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