FDA gives 510(k) approval to Accula Flu A/Flu B test for influenza diagnostics.- Mesa Biotech.

Mesa Biotech announced that it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the FDA for its Accula Flu A/Flu B test. The company's Flu A/Flu B test cassette will be its first available test in the U.S. market. This announcement follows its CE Mark certification and launch of the Flu A/Flu B test last month in Europe.

The CLIA-waived Accula Flu A/Flu B test brings PCR testing to the POC providing a qualitative result in approximately 30 minutes to guide same day treatment decisions. The Accula Testing System offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.