Diazyme Receives 510(K) FDA Approval for Glycated Serum Protein Assay Kit

Diazyme Receives 510(K) FDA Approval for Glycated Serum Protein Assay Kit

SAN DIEGO, CA – October 29, 2004 - Diazyme Laboratories, a company that applies its proprietary Substrate Trapping-Enzyme Technology®(STE) platform to develop low cost and high quality diagnostic products for clinical and research uses, announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(K) clearance to market their Enzymatic Glycated Serum Protein (GSP) Assay Kit for the quantitative in vitro determination of glycated serum proteins in human serum.

The Diazyme enzymatic assay for glycated serum proteins (GSP) uses a proteinase to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme's specific Fructosyl Amine-Oxygen Oxidoreductase, a microorganism originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield amino acids, glucosone and H2O2. The H2O2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at 550 nm is proportional to the concentration of glycated serum proteins (GSP).

Key Assay Characteristics: Diazyme's enzymatic Glycated Serum Protein assay is a two reagent (R1 and R2) based endpoint assay system. The results are obtained in 10 minutes by measuring absorbance at 550nm. No off line pretreatment is needed. The assay has excellent accuracy and precision with a wide measuring range (0 to 1200 µmole/L).

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