Quidel, a US-based virology assays and molecular diagnostic systems provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer.
It is used for rapid, objective detection of elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy.
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 minutes of application of the patient’s specimen.
Sofia is the brand name for Quidel’s next-generation, immunoassay system.
Quidel president and CEO Douglas Bryant noted the developing women’s health assays like the Sofia hCG FIA is a natural expansion opportunity for 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.
The Sofia Analyzer was 510(k) cleared in October of 2011, and its first test, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the FDA in April of 2012.
The company also sells the Sofia Strep A FIA, which received FDA clearance in June 2013.