Gold Standard Diagnostics Corp, Davis, Calif, has received 510k FDA Clearance for its 25-OH Vitamin D, Total ELISA.

Gold Standard DxThe assay strongly correlates with established LC/MS, EIA, and Chemiluminescence methods and offers high sensitivity and specificity over a wide dynamic range. 

The assay features a simple pretreatment step that allows for complete automation on virtually any open ELISA processor.

Because of the pretreatment step and automation capability, the assay provides fast and consistent results.

All assay protocol steps are completed in a standard microtiter plate, without the need for labor-intensive, time-consuming, and complicated pretreatment done manually outside of the analyzer.

[Source: Gold Standard Diagnostics]