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FDA clearance for Alere Reader platform, 6/17

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June 2017—Alere announced that its Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a variety of lateral flow immunoassay formats and that can be used in point-of-care and laboratory settings, received FDA 510(k) clearance. The Alere Reader will be 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, according to the company. Alere expects to submit an application for a CLIA waiver of the Alere BinaxNow Influenza A & B Card 2 test for use on the Alere Reader.

At the point of care, providers can use the Alere Reader to obtain highly accurate results within an actionable time frame and then administer the appropriate treatment. After the test card is inserted into the platform, it detects, identifies, and analyzes the completed lateral flow assay. Results are displayed on an intuitive touchscreen, can immediately be linked to patient electronic medical records and back-end information systems, or can be printed. The analyzer also has an automated function that ensures quality controls have been tested.

Alere, 781-647-3900

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