Quidel seeks 510 (k) Clearance for QuickVue Influenza A+B Test complying FDA’s Class II RIDT Requirements

Quidel Corporation who is known for providing diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, sought 510 (k) Clearance from the United States FDA for Quidel’s CLIA Waived QuickVue Influenza A+B assay for the rapid detection of A and B types of inffluenza.

Quidel’s QuickVue Influenza A+B test was shown to meet the FDA’s reclassification criteria for Class II Rapid Influenza Diagnostic Tests and is available for sale in the United States. The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients.

Douglas Bryant, president and chief executive officer of Quidel Corporation. said “Influenza is a highly contagious, acute, viral infection of the respiratory tract, and rapid diagnosis is critical to avoid potentially serious complications. Recent CDC figures and positivity rates from our Sofia analyzers suggest that this year’s influenza season may be getting worse, not better, and has surpassed the rate of every other year except the unusual pandemic of 2009. Quidel’s QuickVue Influenza A+B test identifies and differentiates influenza type A and B in approximately 10 minutes aiding in better patient management decisions for healthcare professionals.”