Diazyme Receives FDA 510(k) Clearance for Low Cost Enzymatic Creatinine Assay
FOR IMMEDIATE RELEASE
May 03, 2007
SAN DIEGO, CA -- (MARKET WIRE) -- May 03, 2007 -- Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its Enzymatic Creatinine Assay Kit for the quantitative determination of creatinine in serum and urine samples. The Diazyme method is a liquid stable, two reagent system which uses coupled enzyme reactions which are more specific and sensitive than conventional non-enzymatic methods.
The assay features a reduced sample size requirement which is ideal for neonatal testing with specimen requirements as low as 4-8 µL per test. The method also provides an improved interference profile with no significant interferences from bilirubin to 16 mg/dl, hemoglobin to 200 mg/dl, triglycerides to 1000 mg/dl and ascorbic acid to 50 mg/dl. Compared to the colorimetric Jaffe methods for creatinine which are caustic (picric acid) and can stain analyzer tubing and cuvette, the Jaffe method gives a 20% false elevation of creatinine at the low creatinine concentration range. Diazyme enzymatic method is non-caustic, non-staining and has no costly hazardous shipping requirements. Instrument parameters are available for a wide array of analyzers with a choice of packaging formats suitable for use in laboratories of all volumes and workflows.
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, renal disease 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 May 3, 2007