BinaxNOW Influenza A & B Card 2 diagnostic test and reader get 510(k) clearance from FDA - Alere

Alere announced that its Alere Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, has received 510(k) marketing clearance from the US Food and Drug Administration (FDA). The Alere Reader will be initially available for use with the BinaxNOW Influenza A & B Card 2, with other lateral flow applications and assays to follow.

This reformulated test card is the first rapid antigen influenza test to achieve 510(k) clearance as a Class II assay under the new FDA reclassification requirements. With the intent to expand the settings in which this platform can be deployed, Alere expects to promptly submit an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere BinaxNOW Influenza A & B Card 2 test for use on the Alere Reader.

Comment: The Alere i influenza A & B test received FDA CLIA waiver and was approved for marketing in 2014.