Beckman Coulter receives FDA clearance on Vitamin D Total Assay for use on Access 2 and UniCel DxI immunoassay systems

Jan. 19, 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. Company representatives characterize the new assay as an important addition to the company’s bone metabolism assay menu. It is available for use on Beckman Coulter’s 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,” says 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 worldwide.

“Alignment with this internationally recognized reference measurement procedure provides increased confidence that patients will be correctly assessed for vitamin D deficiency or insufficiency,” says Michael Samoszuk, MD, chief medical officer, Beckman Coulter Diagnostics.

Beckman Coulter spokespersons say that new assay also provides excellent stability, greater ease-of-use, and convenient storage through innovative new packaging designed to prevent light-induced reagent degradation, and that laboratories will also benefit from the speed and flexibility provided by the company’s numerous instrumentation options, including the UniCel DxI 800.

Read more on the Beckman Coulter website