Oct. 31, 2017—Abbott has secured FDA 510(k) clearance for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics.
The Alinity ci-series design is based on customer insights, resulting in a number of benefits that include a patented stacked design, instead of linear, which makes it half the size of existing systems; throughput of more than 650 tests per hour per square meter, with the capability to scale up for greater throughput and the ability to run urgent tests without waiting for prior samples to complete testing; and continuous access to solutions and supplies, giving labs the ability to add tests and reagents without pausing or stopping instruments or testing cycles for prolonged periods of time.
“Alinity ci was designed using a different approach. We went beyond traditional market research and spent countless hours with our customers, listening to their challenges and observing how they work,” John Frels, vice president of immunoassay and clinical chemistry research and development at Abbott, said in a statement. “With customer insights as our road map, the Alinity ci is engineered to simplify diagnostic testing while ensuring speed, accuracy, and performance.”
The Alinity c clinical chemistry system and the Alinity i immunoassay system can operate individually or as an integrated Alinity ci-series unit. In addition to the instrument clearance, several clinical chemistry and immunoassay tests are now cleared in the United States for the system, with a comprehensive menu of tests expected to be available within a year of launch.