Alere Reader, a point-of-care influenza diagnostic, gains 510(k) clearance

WALTHAM, Mass. – Alere on Tuesday 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 U.S. Food and Drug Administration.



“The Alere BinaxNOW Influenza A & B Card 2 test with the Alere Reader, improves what is already a leading rapid testing solution for influenza diagnosis in two key ways - by eliminating operator subjectivity and by connecting test results with information management systems,” stated Avi Pelossof, Alere Global president of infectious disease. “The Alere Reader platform, paired with Alere’s market-leading lateral flow portfolio, will ensure that over time this novel technology will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings.”



With the Alere Reader, physicians, lab technicians and other healthcare personnel insert test cards into the platform, which detects, identifies and analyzes the completed lateral flow assay. Results are displayed on an intuitive touch screen, can immediately be linked to patient electronic medical records and back-end information systems, or can be printed. Further, the Alere Reader provides the user additional confidence in the results with an automated function that ensures quality controls have been tested.



This announcement represents the introduction into the U.S. market of the Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities. This follows a successful release of the Alere Reader into Europe and select Asian markets.