FDA Grants Diazyme 510(k) Clearance to Market Its Vitamin D Assay for Clinical Chemistry Analyzers
Source Newsroom: 2014 AACC Annual Meeting Press Program
Newswise — Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its Vitamin D assay for Clinical Chemistry Analyzers. In line with the rapid increasing clinical demands for testing of this important biomarker, Diazyme’s new Vitamin D assay, utilizing its femtoquantTM technology (a sensitive homogenous enzyme-immunoassay platform), provides the first fully automated Vitamin D test for use on general clinical chemistry analyzers. Diazyme’s Vitamin D assay measures total 25-hydroxy Vitamin D (sum of 25-(OH)D3 + 25-(OH)D2 ) levels.
“Diazyme’s Vitamin D assay is the first and the only Vitamin D test that is specifically designed for use on clinical chemistry analyzers. This innovative Vitamin D assay enables clinical laboratories of virtually all sizes to run Vitamin D test in house without the need for expensive specialized instruments. This high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods. Diazyme’s Vitamin D assay can help clinical laboratories improve their workflow and reduce their turnaround time for test results.” said Dr. Chong Yuan, Managing Director of Diazyme Laboratories.
Diazyme Laboratories is a division of General Atomics headquartered in La Jolla, California. Diazyme uses its unique platform technologies to develop innovative assays for clinical and research uses with reduced costs and improved performance. Products include diagnostic blood tests for cardiac markers, diabetes, nutritional assessment, liver disease, renal disease and electrolytes. Information regarding Diazyme’s enzyme technology and related products can be found on its website at www.diazyme.com.
For Further Information Contact:
Dr. Abhijit Datta, Ph.D