Skip to main content
Premium Trial:

Request an Annual Quote

Alere Gets 510(k) Clearance for Reader Platform and Influenza Assay

NEW YORK (360Dx) – Alere said today that the US Food and Drug Administration has given 510(k) clearance for its Alere Reader, a camera-based diagnostic analyzer that quickly reads and interprets lateral flow tests and can be used in both point-of-care and laboratory settings.  

Alere noted that the reader will be available for use with the BinaxNOW Influenza A & B Card 2, an in vitro immunochromatographic assay used for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. The reader will be available later with other lateral flow applications and assays.  

The assay, which has been reformulated, is the first rapid antigen influenza test to achieve 510(k) clearance as a Class II assay under the new FDA reclassification requirements, Alere said.

FDA clearance triggers the introduction of the Alere reader into the US market, which follows its release in Europe and select Asian markets after it received CE marking in August 2016.

Alere noted that it will promptly apply for a CLIA-waiver for use of the reader with the influenza assay, in order to expand the settings in which the platform can be deployed. The diagnostic platform provides objective result interpretation and connectivity capabilities that can be used to evaluate a wide variety of lateral flow immunoassay formats, Alere said.

Combining the analyzer and assay "improves what is already a leading rapid testing solution for influenza diagnosis in two key ways," Avi Pelossof, Alere's global president of infectious disease, said in a statement, adding that it eliminates operator subjectivity and connects test results with information management systems.

Over time the analyzer and assay will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings, Pelossof said.

The analyzer supports key goals of healthcare and regulatory stakeholders by ensuring the accuracy and reproducibility of test results, Alere said. By using the device at the point of care, providers can obtain accurate results within an actionable timeframe and then quickly administer the appropriate treatment. 

The reader is part of Alere’s flu portfolio that includes the Alere i Influenza A & B, which is the first CLIA-waived molecular flu test, and the Alere Influenza A & B dipstick test.