FDA Clearance for Quidel Sofia(R) RSV Fluorescent Immunoassay (FIA)

Quidel Corporation has received 510(k) clearance from the FDA for its Sofia RSV FIA test for use with the Sofia Analyzer for the rapid, objective detection of respiratory syncytial virus (RSV) infections.

Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia RSV FIA employ 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 fifteen (15) minutes of application of the patient's specimen.

The 510(k) clearance allows Quidel to market and sell its new Sofia RSV FIA in the United States. The Sofia Analyzer was 510(k) cleared in October of 2011 and CLIA-waived in April 2012. In addition to the RSV FIA, Sofia now enables rapid immunofluorescence assays for three other FDA-cleared FIAs: Influenza A+B, Strep A and hCG for pregnancy.