FDA clearance for 25-Hydroxy Vitamin Ds EIA Test

FDA clearance for 25-Hydroxy Vitamin Ds EIA Test

Immunodiagnostic Systems Limited (IDS), a leading solution provider to the clinical laboratory diagnostic market, today announced it has received the USA FDA (Food and Drug Administration) 510(k) clearance for 25-Hydroxy Vitamin Ds EIA test kit.

This assay aligns with a reference measurement procedure used in the Vitamin D Standardization Program (VDSP) for vitamin D measurement.  It has also been among the first 25 vitamin D commercialised test certified by the Centers for Disease Control (CDC) Vitamin D Standardization Certification Program (VDSCP).

The National Institutes of Health (NIH) Office of Dietary Supplements (ODS) established the Vitamin D Standardization Program (VDSP) in November 2010. Part of the ODS Vitamin D Initiative, VDSP is an international collaborative effort to standardise the laboratory measurement of vitamin D status.

Market value of 25 Vitamin D testing is estimated to be circa $135 million per annum in the USA.

Continuing IDS’ heritage and expertise in endocrinology and Vitamin D testing, IDS provides VDSP certified tests, 25-Hydroxy Vitamin Ds EIA and fully automated IDS-iSYS 25-Hydroxy Vitamin Ds which enhance accuracy and reliability in vitamin D testing and enables clinicians to generate reproducible and comparable results.