Quidel Corporation announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its Sofia™ Analyzer and its Sofia Influenza A+B FIA.
Sofia is the brand name for Quidel's next generation immunoassay system. The easy-to-use Sofia Analyzer and Sofia Influenza A+B FIA combine unique software and fluorescent chemistry to yield an automatic, objective result that is readily available on the instrument's screen, in a hard-copy printout, and in a transmissible electronic form that can network via an LIS system to hospital and medical center databases. The Sofia FIA employs advanced lateral flow and immunofluorescence technologies to provide enhanced clinical sensitivity for influenza A and B. The Sofia Analyzer provides for different operational modes to accommodate both small and large laboratories, as well as other features designed to facilitate use in a variety of healthcare settings, including hospitals, medical centers, and small clinics. These features help ensure a reliable, objective, rapid, and accurate diagnostic result.
"We are very pleased with the FDA clearance of our Sofia Analyzer and Sofia Influenza A+B FIA," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "This announcement represents the achievement of a significant milestone, and positions us in the marketplace with a strategically important platform that will provide numerous benefits to healthcare providers and their patients."
The Sofia Influenza A+B Fluorescent Immunoassay is the first in a series of new Quidel immunofluorescent assays for infectious disease and other conditions or disorders that will use the very same Sofia Analyzer. The 510(k) clearance grants Quidel permission to sell both the Sofia Analyzer and the Sofia Influenza A+B FIA in the United States in advance of the upcoming influenza and respiratory disease season. Both the Sofia Analyzer and the Sofia Influenza A+B FIA received the CE Mark in August 2011, and are thus already available for sale in Europe and other ex-U.S. locations, and they are now available for commercial distribution in the United States.