Diazyme Receives 510(K) FDA Approval for Enzymatic Homocysteine Assay Kit

Diazyme Receives 510(K) FDA Approval for Enzymatic Homocysteine Assay Kit

SAN DIEGO, CA - Oct. 29, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) to develop low cost and high quality diagnostic products for clinical and research uses, announced that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market the Enzymatic Homocysteine Assay Kit.

Diazyme has developed an assay kit to determine plasma homocysteine levels based onits proprietary co-substrate conversion product based enzyme cycling method. The assay involves no immunochemical reactions and requires less blood sample volume than immuno assays.

Key Assay Characteristics: Diazyme's Enzymatic Homocysteine assay is a two or three reagent (R1 and R2 or R1, R2, and R3) based cycling assay system. The results are obtained in 10 minutes by measuring absorbance at 340nm. No off line pretreatment is needed. The assay has excellent accuracy and precision with a wide measuring range (2 to 50 µmole/L).

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