Quidel Wins FDA Clearance for Sofia(R) hCG FIA

Quidel Corporation

, 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(R) 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(TM) 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.