Beckman Coulter Diagnostics, a global leader in developing clinical diagnostics products has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Access 25(OH) Vitamin D Total assay. The assay can be used on the company’s Access 2 and UniCel DxI series of immunoassay systems.
The Access 25(OH) Vitamin D Total assay is a chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D levels in human serum and plasma. Results are to be used as an aid in the assessment of vitamin D sufficiency. Laboratories will also benefit from the speed and flexibility provided by the company’s immunoassay systems, including the Access II and UniCel DxI 800, thus reducing the number of process steps and providing better turnaround time.
Beckman Access II is a bench top immunoassay analyzer that offers a sample management capacity of up to 60 samples at one time in 6 trays of 10 samples each. The device’s bar-coded reagents allow automatic tracking of the number of tests administered, available tests, lot number, expiration date and calibration expiration. By using this immunoassay System, Vitamin D Total assay offers a maximum throughput of up to 100 tests per hour.
The assay features innovative packaging designed to prevent light-induced reagent degradation, while offering high stability, greater ease of use, and convenient storage. Reliable lab equipment suppliers offer Beckman Access 25(OH) Vitamin D Reagents and Calibrators that can be used with the company’s immunoassay systems.
According to Arnd Kaldowski, president, Beckman Coulter Diagnostics, “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”.
Through standardization to the gold standard 25 (OH) vitamin D reference measurement procedures (RMP) from Ghent University, the new assay delivers increased accuracy in patient results. The Ghent RMP reference procedure utilized by the Vitamin D Standardization Program (VDSP), aims at promoting standardized laboratory measurements of 25(OH) vitamin D around the world. The measurement procedure also provides more confidence that patients will be correctly assessed for vitamin D deficiency or insufficiency.
Beckman Coulter has recently added yet another new assay to its Access Family of Immunoassay Systems. The new Access TSH (3rd IS) assay helps to maximize laboratory workflow with a larger reagent pack size (100 tests/pack, 200 tests/kit) that improves laboratory efficiency.