Abbott, Abbott Park, Ill, has secured FDA premarket notification (510(k)) clearance for its Alinity ci series instruments for clinical chemistry and immunoassay diagnostics. The testing systems were designed to help labs address modern diagnostic sector challenges—including aging populations, increased incidence of chronic diseases under management, and increased access to care—which together are driving increases in testing volume.
Brian Blaser, Abbott.
“Healthcare systems across the United States are under pressure to deliver better care for patients,” says Brian Blaser, executive vice president for diagnostic products at Abbott. “Labs and healthcare systems are looking for complete solutions that help them operate more efficiently while contributing to better clinical decisionmaking and helping improve patient outcomes. FDA clearance is a key first step in bringing this important innovation to our US customers, as we work to gain approval for the full Alinity portfolio of instruments and assays.”
The Alinity ci series is part of a unified family of instruments that are engineered for flexibility and efficiency. Their design is based on insights from thousands of customers, resulting in a number of benefits, including a smaller footprint, greater throughput, reduced wait time, and simplified design for error proofing.
The Alinity c clinical chemistry system, and the Alinity i immunoassay system, can operate individually or as an integrated Alinity ci series unit, allowing for greater productivity in half the footprint of current diagnostics systems. In addition to the instrument clearance, several clinical chemistry and immunoassay tests are now cleared for use on the system in the United States, with a comprehensive menu of tests expected to be available within a year of launch. The Alinity ci series obtained the CE mark earlier this year and is available in Asia, Europe, Latin America, and the Middle East.
John Frels, PhD, Abbott.
“Alinity ci was designed using a different approach,” says John Frels, PhD, vice president for immunoassay and clinical chemistry research and development at Abbott. “We went beyond traditional market research and spent countless hours with our customers, listening to their challenges and observing how they work. With customer insights as our roadmap, the Alinity ci is engineered to simplify diagnostic testing while ensuring speed, accuracy and performance.”
