510(k) for hCG fluorescent immunoassay

SAN DIEGO, California-based Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer for the rapid, objective detection of elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy. 

Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia hCG FIA with proprietary Kinetic Check? Technology combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure a reliable, objective, highly accurate, diagnostic result within three (3) minutes of application of the patient's specimen.

"Historically, Quidel has been an infectious disease and women's health company with considerable technical expertise in both segments, and so, to us, the development of women's health assays like the Sofia hCG FIA, is a natural expansion opportunity," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "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."

The 510(k) clearance allows Quidel to market and sell its new Sofia hCG FIA in the United States.Mujer