FDA gives 510(k) approval for the Accula RSV test for diagnosing respiratory syncytial virus.- Mesa Biotech.

Mesa Biotech announced that it received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the FDA for its Accula RSV test. The respiratory syncytial virus or RSV test cassette is cleared for diagnosing both children and adult populations.

The Accula RSV test is the second molecular POC diagnostic on the Accula platform to receive FDA clearance and CLIA waiver, following the company's Flu A/Flu B test, cleared earlier this year. The Accula molecular test system provides the superior sensitivity, specificity and information content of laboratory-based PCR testing, while offering the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, with its palm-sized, reusable dock and disposable test cassettes.