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Quidel Sofia hCG fluorescent immunoassay wins FDA 510(k) clearance

PBR Staff Writer Published 06 August 2013

Quidel has won FDA 510(k) clearance for its Sofia hCG fluorescent immunoassay (FIA) for use on the Sofia Analyzer to detect elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy.

The Sofia Analyzer and Sofia hCG FIA with Kinetic Check technology bring together immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems.

The systems are designed to ensure a reliable, objective, precise, diagnostic result in less than three minutes of application of the patient's specimen.

Quidel president and chief executive officer Douglas Bryant said the development of women's health assays like the Sofia hCG FIA, is a natural expansion opportunity to the company.

"We are pleased to receive clearance for this assay because we believe Sofia's accuracy and speed can play a vital role in medical settings, such as obstetrics and gynecology, where important patient decisions are made every day," Bryant added.

With the 510(k) clearance, Quidel will now market and sell its new Sofia hCG FIA in the US.