FDA grants Diazyme 510(k) clearance to market its vitamin D assay for clinical chemistry analyzers
Diazyme Laboratories has announced that the U.S. Food and Drug Administration has granted 510(K) clearance to market its Vitamin D assay for clinical chemistry analyzers. In line with the rapidly increasing clinical demands for testing of this important biomarker, Diazyme’s new Vitamin D assay, utilizing its Femtoquant technology (a sensitive homogenous enzyme-immunoassay platform), provides a 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 enables clinical laboratories of virtually all sizes to run Vitamin D tests in-house without the need for expensive specialized instruments,” says Chong Yuan, PhD, Managing Director of Diazyme Laboratories. “This high-throughput liquid stable assay provides precise test results, is user-friendly and cost-effective, and has excellent correlation to the existing commercial methods.”
Other solutions provided by La Jolla, California-based Diazyme include diagnostic blood tests for cardiac markers, diabetes, nutritional assessment, liver disease, renal disease, and electrolytes. Learn more about Diazyme’s enzyme technology and related products.
