Diazyme Receives FDA 510(k) Clearance and NGSP Certification for Its Direct Enzymatic HbA1c Assay Product
SAN DIEGO, CA--(MARKET WIRE)--Apr 19, 2007 -- Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Direct Enzymatic Hemoglobin A1c (HbA1c) Assay Kit for the quantitative determination of HbA1c in human whole blood samples.
The company also announced today that it has successfully completed the National Glycohemoglobin Standardization Program (NGSP; www.ngsp.org) manufacturer certification for this assay. The Diazyme Direct Enzymatic HbA1c method is now traceable to the Diabetes Control and Complications Trial (DCCT) reference method.
HbA1c is an important test recommended by the American Diabetic Association (ADA) for monitoring patient glycemic status. HbA1c refers to glucose modified hemoglobin A (HbA) specifically at N-terminal valine residues of hemoglobin beta chains.
Diazyme's Direct Enzymatic HbA1c Assay has all the advantages of both the HPLC and immunoassays methods in the areas of accuracy, specificity, applicability to chemistry analyzers and is cost effective, simpler and has no interference from hemoglobin variants. The HbA1c test uses two ready-to-use liquid stable reagents. Since it does not require a separate measurement of total hemoglobin content in the samples, the assay only needs a single channel to perform the test on chemistry analyzers in comparison with some immunoassays that require a separated measurement of total hemoglobin and need two channels for the test on chemistry analyzers. Diazyme's assay requires no post analytic calculations, and the results are directly reported as % of HbA1c.
Key Assay Characteristics:
- Two reagents, liquid stable
- No need for total hemoglobin measurement
- No need for post analytic calculations
- Applicable to most analyzers
- Excellent correlation with HPLC and immunoassays
- No interferences from hemoglobin variants
Diazyme Laboratories is a division of General Atomics headquartered in La Jolla, California. Diazyme uses its platform enzyme technologies including enzyme cycling, Substrate-Trapping-Enzyme (STE), and Allosteric Enzyme Coupled Immunoassay (AECIA), to develop low cost and uniform diagnostic products for clinical and research use. Products include diagnostic blood tests for liver disease, cardiac markers, diabetes and electrolytes. Diazyme's enzyme technology and related products can be found in its website at www.diazyme.com.
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Posted on Thu, April 19, 2007