Diazyme Receives FDA 510(k) Clearance for LDL-Cholesterol Assay
FOR IMMEDIATE RELEASE
Mar 06, 2008
POWAY, CA - March 6, 2008 -- Diazyme Laboratories announced today that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its LDL-Cholesterol Assay Kit for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. Diazyme uses a modified PVS and PEGME coupled classic precipitation method. This homogeneous two reagent system requires no sample pre-treatment and is cost effective and liquid stable. The assay meets National Cholesterol Education Program (NCEP) total error goals for both normal and abnormal high triglyceride samples, making it possible to reliably test non-fasting specimens with triglyceride to 1000 mg/dL. The method is not interfered by triglyceride up to 1000 mg/dL, hemoglobin up to 1,000 mg/dL, bilirubin up to 40 mg/dL and ascorbic acid up to 175 mg/dL. The assay features an extended linear range from 5 mg/dL to 800 mg/dL, has minimal sample size requirement of only 3 µL and is readily adaptable to automated chemistry instrumentation.
General Atomics is a San Diego-based innovation firm with a 50-year history of successful solutions for energy, defense and environmental challenges. Diazyme Laboratories, a division of General Atomics, uses its platform technologies 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 on its website at www.diazyme.com.
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