FDA grants de novo clearance to Sciex’s vitamin D assay for mass spectrometry

25 May 2017 (Last Updated May 25th, 2017 18:30)

The US Food and Drug Administration (FDA) has granted de novo clearance to Sciex’s in-vitro diagnostics unit Sciex Diagnostics’ Vitamin D 200M assay for the Topaz system.

The US Food and Drug Administration (FDA) has granted de novo clearance to Sciex’s in-vitro diagnostics unit Sciex Diagnostics’ Vitamin D 200M assay for the Topaz system.

Vitamin D 200M assay is an LC-MS-based vitamin D assay kit, while Topaz is a fully integrated LC-MS platform that features a new and intuitive software called ClearCore MD.

The analysis of Vitamin D is considered to be necessary to diagnose its stores as well as for the management of diseases caused by its deficiency.

Sciex Diagnostics senior director Dr Aaron Hudson said: “Through the Topaz system, Sciex offers an LC-MS-based IVD system that is easy to learn and validate in the clinical lab.

"LC-MS technology provides specificity and less cross-reactivity during vitamin D testing, compared to immunoassay methods."

“It will enable clinical labs to expand their in-house testing services through the Sciex Vitamin D assay kit, as well as add to their own laboratory-developed tests (LDTs), thus empowering the lab to do more, save more and deliver more confident results to support clinicians and physicians.”

According to the Centres for Disease Control and Prevention (CDC), LC-MS technology provides specificity and less cross-reactivity during vitamin D testing, compared to immunoassay methods.

The Topaz system with Vitamin D 200M assay kit quantitatively separates D2 and D3 isomers, and automatically differentiates various D3 epimers, in a single analysis.

Meant for in-vitro diagnostic use with the Topaz system, the assay can be used for quantitative determination of total 25-hydroxyvitamin D (25-OH-D) by using LC-MS/MS technology to measure 25-hydroxyvitamin D3 (25-OH-D3) and D2 (25-OH-D2) in human serum.