Diagnostic healthcare solutions manufacturer Quidel has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia human chorionic gonadotrophin (hCG) fluorescent immunoassay (FIA).
The 510(k) clearance will allow the company to sell its new product in the US.
Sofia hCG FIA is mainly used on the Sofia Analyzer for detecting the higher levels of hCG to confirm pregnancy.
Equipped with Kinetic Check Technology, the Sofia Analyzer and Sofia hCG FIA combine immunofluorescence chemistry, advanced lateral flow technology, failure alert and fail-safe systems to give accurate, diagnostic result within three minutes of application of the patient’s specimen.
Quidel CEO and president Douglas Bryant said: "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 gynaecology, where important patient decisions are made every day."
The US FDA gave 510(K) clearance to Sofia Analyzer in October 2011, and Clinical Laboratory Improvement Amendments (CLIA) waiver to the Sofia Analyzer’s first test, Sofia Influenza A+B FIA, in April 2012.
In addition to Sofia hCG FIA and Sofia Analyzer, the company also sells the Sofia Strep A FIA, which received 510(k) clearance in June 2013.