5th January 2015 Content supplied by: Quidel Corporation
FDA Clearance and CLIA Waiver for Strep A FIA
- Using the FDA's new dual submission program, Quidel Corporation has received simultaneous FDA clearance and CLIA waiver for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for the rapid detection of infections by Group A Streptococcus bacteria.
Sofia is the brand name for Quidel's next-generation, immunoassay system. The Sofia Analyzer and Sofia Strep A+ FIA combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and fail-safe systems designed to ensure reliable, objective, highly accurate, diagnostic results within five minutes of application of the patient's specimen.
The linked-FDA clearance and CLIA waiver represent the first such achievement of any manufacturer under the FDA's new Dual Submission Program. This program requires a Pre-submission, and allows for simultaneous review of the 510(k) and CLIA waiver applications, substantially reducing the time and effort required for the FDA's review of 510(k) and CLIA waiver submissions that previously required two independent sequential submissions. Successful passage through the Dual Submission Program thus allows the diagnostic industry to pursue its commercial goals sooner, while also more quickly bringing new products to the marketplace where they can serve both physicians and patients.
The CLIA waiver designation for the Sofia Strep A+ FIA allows Quidel to sell the assay to all CLIA categories of laboratories in the United States, including the CLIA-waived segment of the market that is comprised of approximately 30,000 physician offices laboratories and 5,000 hospital emergency departments. It is anticipated that the clearance and CLIA waiver of the Sofia Strep A + FIA will further expand the placement of new Sofia instruments -- a process that has accelerated throughout 2014.
The Sofia Analyzer was 510(k) cleared in October of 2011, and Quidel's first Sofia FIA, the Sofia Influenza A+B FIA, received Clinical Laboratory Improvement Amendments (CLIA) waiver by the FDA in April of 2012. In addition to the Sofia Influenza and Sofia Strep A FIAs, Quidel also markets the CLIA-waived Sofia Respiratory Syncytial Virus (RSV) FIA and the Sofia hCG FIA. Quidel now provides a broad spectrum of FDA-cleared Strep A diagnostic assays that cover the full spectrum of market needs for this pathogen, including two assays on the Sofia platform (one CLIA-waived), three different assays on the QuickVue platform (two CLIA-waived), and two new molecular assays -- AmpliVue Strep A Assay and Lyra Direct Strep Assay (for Streptococcus pathogens of Groups A and C&G).
Date Published: 5th January 2015
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