Diazyme Receives 510(K) FDA Approval for Enzymatic Hemoglobin A1c Assay Kit


Jul 18, 2005

SAN DIEGO, CA - July 12, 2005 - Diazyme Laboratories, a company that applies its proprietary protein engineering and SubstrateTrapping-Enzyme Technology® (STE) platforms 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 Hemoglobin A1c (HbA1C) Assay Kit for the quantitative determination of HbA1c in human whole blood samples. Diazyme Laboratories is a division of General Atomics.

HbA1c is an important test recommended by the American Diabetic Association (ADA) for monitoring patient glycemic status. Glycohemoglobin is produced by non-enzymatic addition of glucose to amino groups in hemoglobin. HbA1c refers to glucose modified hemoglobin A (HbA) specifically at N-terminal valine residues of hemoglobin beta chains. Diazyme's HbA1c test is an enzymatic assay in which lysed whole blood samples are subjected to extensive protease digestion. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as a substrate for recombinant fructosyl valine oxidase (FVO) enzyme, produced in E. coli. FVO specifically cleaves N-terminal valines and produces hydrogen peroxide. This, in turn, is measured using a horse radish peroxidase (POD) catalyzed reaction and a suitable chromagen. HbA1c is expressed as a percentage of the total hemoglobin (THb) which is determined separately.

Key Assay Characteristics:

  • Whole blood specimens are used in the assay. No extra steps needed to separate RBCs.

  • All liquid stable reagents. Easy to use on automated chemistry analyzers

  • No latex or bead based components. Reagents do not coat cuvettes or clog analyzer lines.

  • Excellent performance characteristics with CV% of < 5%

  • Excellent correlation to HPLC method

  • No interferences from acetylated, carbamylated or labile HbA1c.

  • Variant Hemoglobin S and C do not affect results.

For additional information please call (858)455-4768 or email


Business - Steve O'Hara, Diazyme Laboratories, (858) 455-3911

Public Relations - Doug Fouquet, General Atomics, (858) 455-2173

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