Beckman Coulter Receives FDA Clearance on Vitamin D Total Assay for Use on Access 2 and UniCel DxI Immunoassay Systems

Newswise — BREA, CALIF. — (January 7, 2015) — Beckman Coulter Diagnostics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Access 25(OH) Vitamin D Total assay. Offering state-of-the-art performance, the new assay is an important addition to the company’s bone metabolism assay menu and is available for use on its Access 2 and UniCel DxI series of immunoassay systems. "FDA clearance of our 25(OH) Vitamin D Total assay allows us to provide laboratories with the tools needed to confidently diagnose and manage vitamin D deficiency-related diseases," said Arnd Kaldowski, president, Beckman Coulter Diagnostics. "The new assay delivers increased accuracy in patient results through traceability to the gold standard 25(OH) vitamin D reference measurement procedure (RMP) from Ghent University and equimolar detection of 25(OH) vitamin D2 and 25(OH) vitamin D3."

The Ghent RMP is the reference procedure utilized by the Vitamin D Standardization Program (VDSP), an international collaboration established by the Office of Dietary Supplements at the National Institutes of Health, with the goal of promoting standardized laboratory measurements of 25(OH) vitamin D around the world. "Alignment with this internationally recognized reference measurement procedure provides increased confidence that patients will be correctly assessed for vitamin D deficiency or insufficiency," said Michael Samoszuk, MD, chief medical officer, Beckman Coulter Diagnostics.

The new assay also provides excellent stability, greater ease-of-use and convenient storage through innovative new packaging designed to prevent light-induced reagent degradation. Laboratories will also benefit from the speed and flexibility provided by the company’s numerous instrumentation options, including the UniCel DxI 800, the industry’s highest throughput immunoassay analyzer.

About Beckman Coulter

Beckman Coulter Diagnostics develops clinical diagnostic products that help advance and optimize the clinical laboratory. Based in Brea, Calif., Beckman Coulter’s instruments, systems and tests help streamline processes to enhance efficiency, reduce costs and speed the delivery of results. For more than 80 years, Beckman Coulter has been a global leader devoted to providing solutions to laboratories of all sizes—offering a broad portfolio of chemistry, immunoassay, hematology, urinalysis, automation and information systems. Beckman Coulter is, and always has been, singularly devoted to moving science, innovation and the lab forward. For more information, visit www.beckmancoulter.com.

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