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FDA grants Diazyme 510(k) clearance to market Vitamin D assay for Clinical Chemistry Analyzers

Diazyme Laboratories has announced that the US 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 Femtoquant 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 Laboratories managing director Dr Chong Yuan noted the company Vitamin D assay is the first and the only Vitamin D test that is specifically designed for use on routine 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," Dr Yuan added.