FDA has granted premarket notification (510(k)) clearance for the Alere Reader, from Alere Inc, Waltham, Mass. Suited for use in both point-of-care and laboratory settings, the diagnostic analyzer will initially be available for use with the BinaxNow influenza A & B card 2, with other lateral-flow applications and assays to follow.
The Alere Reader is a diagnostic system that features objective results interpretation and connectivity capabilities, and can be used to evaluate lateral-flow immunoassays in a wide variety of formats. The Reader was previously released into Europe and select Asian markets in August 2016, after receiving the CE mark.
To expand the settings in which the platform can be deployed, Alere expects to submit an application for waived status under the Clinical Laboratory Improvement Amendments of 1988 for the Alere BinaxNow influenza A & B card 2 test for use on the Alere Reader.
“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,” says Avi Pelossof, global president of infectious disease at Alere. “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.”
The Alere Reader supports key goals of healthcare and regulatory stakeholders by ensuring the accuracy and reproducibility of test results. By utilizing the Alere Reader at the point of care, providers can obtain accurate results within an actionable timeframe, and then administer the appropriate treatment.
With the Alere Reader, physicians, lab technicians, and other healthcare personnel insert test cards into the instrument, 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 required quality control tests have been performed.
For more information, visit Alere.