Sciex Diagnostics, Framingham, Mass, has received FDA de novo clearance for its liquid chromatography–mass spectrometry (LC-MS) based vitamin D 200M assay, exclusively for the Sciex Topaz system. The Topaz system is a fully integrated LC-MS platform driven by ClearCore MD, intuitive software designed specifically for use in clinical labs. While individually quantitating D2 and D3 isomers, the Topaz system also automatically differentiates between D3 epimers, providing the specificity to deliver highly accurate diagnostic results in a single analysis. The system is intended for in vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D through the measurement of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in human serum using LC-MS/MS technology by a trained laboratory professional in a clinical laboratory. For more information, visit Sciex.