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

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.