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Alere Receives FDA Clearance for Modified Influenza A & B Test

NEW YORK (360Dx) – The US Food and Drug Administration has issued 510(k) clearance for the Alere i Influenza A & B panel, Alere i Influenza A & B control swab kit, and the Alere i instrument.

The agency late last month issued the clearance, which allows Alere to market the device in the US.

The Alere i Influenza A & B assay performed on the Alere i instrument is a rapid molecular IVD test that uses isothermal nucleic acid amplification technology. Alere sent a special 501(k) submission because of a modification to the Alere i Influenza A & B panel, in which an additional molecular beacon was added to address an identified mismatch with certain Flu B strains, FDA said.

The Alere i platform allows for the rapid molecular detection of RSV, Influenza A & B, and Strep A, according to Alere.

In August 2016, Alere received 510(k) clearance for the Alere i RSV test, which detects respiratory syncytial virus infection in children and adults from nasopharyngeal swab samples in 13 minutes or less.

In June 2014, FDA cleared the Alere i molecular platform for the detection and differentiation of influenza A and B virus, and in March of the same year the agency cleared Alere’s strep A test.