A 510(k) clearance, or a Premarket Notification, requires device manufacturers to notify the FDA at least 90 days ahead of registration with their intent to market a medical device.
Medical technology company BD (Becton, Dickinson and Company) has announced that the FDA has granted 510(k) clearance for its diagnostic combination test which identifies and differentiates COVID-19, influenza A, influenza B, and respiratory syncytial virus (RSV). According to a press release from BD, the test, BD Respiratory Viral Panel (RVP) for BD MAX System, delivers a result in approximately 2 hours.1
A single nasal swab or nasopharyngeal swab sample is used by the test to determine if a patient has RSV, COVID-19, or influenza A/B. The multi-testing feature allows for increased testing capacity ahead of the fall season, when influenza and RSV seasons generally arrive.1
A 510(k) clearance, or a Premarket Notification, requires device manufacturers to notify the FDA at least 90 days ahead of registration with their intent to market a medical device. This gives the federal agency time to determine if the proposed device is “equivalent” to a device already in 1 of 3 classifications.2
Through an Emergency Use Authorization (EUA) from the FDA, the test has been available since February. According to BD, each BD MAX System is “capable of analyzing hundreds of samples over a 24-hour period.” The test is an RT-PCR assay that makes the distinction between the conditions in approximately 2 hours through the “walkaway workflow” of the BD MAX System, allowing for minimal human interaction.1