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# FDA Clears Sciex Vitamin D Assay
- URL: https://www.fdaweb.com/fda-clears-sciex-vitamin-d-assay/
- Published: 2017-05-24T12:00:00.000Z
- Updated: 2026-09-14T22:25:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138773

FDA has granted a *de novo* clearance for Sciex Diagnostics’ LC MS-based Vitamin D 200M Assay for use on the company’s Topaz System. “The CDC has established a Vitamin D Standardization-Certification Program (VDSCP) and the SCIEX Topaz Vitamin D 200M Assay Kit has successfully met the rigorous performance criteria,” the company says. “While individually quantitating D2 and D3 isomers, the Topaz System running the Vitamin D 200M Assay Kit also automatically differentiates between D3 epimers, providing the specificity to deliver highly accurate diagnostic results in a single analysis.” Additionally, the device provides a quantitative determination of total 25-hydroxyvitamin D through the measurement of 25-hydroxyvitamin D3 and 25-hydroxyvitamin D2 in human serum.