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FDA Clears Abbott's Alinity ci-Series Diagnostic Systems

NEW YORK (360Dx) – The US Food and Drug Administration has granted 510(k) clearance for a line of clinical chemistry and immunoassay diagnostic instruments from Abbott, the firm announced today.

The Alinity c clinical chemistry system and Alinity i immunoassay system can be used individually or as an integrated Alinity ci-series unit, Abbott noted in a statement, adding the ci-series instruments have half the footprint of existing systems due to its stacked design.

The ci-series also features a simplified lock-and-key design for reagent bottles to prevent errors, an improved workflow, and a throughput of more than 650 tests per hour per square meter, "a significant increase compared to other available systems, with the capability to scale up for even greater throughput and the ability to run urgent tests without waiting for prior samples to complete testing," the firm said.

The ci-series obtained CE marking in early 2017 and it is currently available in Europe, the Middle East, Asia, and Latin America. In a Q3 earnings call last week, the firm noted that it expects to initiate the US launch of its Alinity systems in 2018. Abbott had previously announced that it would debut tests for the Alinity ci-series in phases, with a complete menu of around 200 clinical chemistry tests and immunoassays available within a year of launch.