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Abbott Diagnostics seeks FDA approval for vitamin D assay

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ABBOTT PARK, Ill. — Abbott Diagnostics on Friday announced its filing of a submission for clearance by the Food and Drug Administration for a fully automated vitamin D assay performed on its Architect testing system for use by healthcare professionals.

"Increasing interest in vitamin D is fueling a surge in orders for tests as more healthcare professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks," stated Sudarshan Hebbar, senior medical director of Abbott Diagnostics.

The Architect 25-OH Vitamin D assay is a fully automated immunoassay intended to help laboratories manage their increasing vitamin D testing volumes through the quantitative determination of 25-hydroxy vitamin D in human serum and plasma to aid in the assessment of vitamin D sufficiency.

"Research shows that vitamin D levels are a concern for patients with osteoporosis, chronic kidney disease, malabsorption and anyone with a condition or taking a medication that may impair bone health," said Brian Blaser, SVP at Abbott Diagnostics. "This new fully automated vitamin D assay may help physicians better diagnose and counsel patients with suspected vitamin D deficiency."

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