Abbott has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Alinity™ ci-series instruments for clinical chemistry and immunoassay diagnostics. These innovative testing solutions were designed to help the lab more effectively address modern industry challenges, including aging populations, growing management of chronic diseases and increased access to care, which are driving increases in testing volume.
"Healthcare systems across the United States are under pressure to deliver better care for patients," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "Labs and healthcare systems are looking for complete solutions that help them operate more efficiently while contributing to better clinical decision making and helping improve patient outcomes. FDA clearance is a key first step in bringing this important innovation to our U.S. 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 personalized solutions that are engineered for flexibility and efficiency. The design is based on insights from thousands of customers, resulting in a number of benefits including:
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 in the U.S. for the system, with a comprehensive menu of tests expected to be available within a year of launch. The Alinity ci-series obtained CE Mark earlier this year and is available in Europe, Middle East, Asia and Latin America.
"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," said John Frels, Vice President, Immunoassay and Clinical Chemistry Research and Development. "With customer insights as our roadmap, the Alinity ci is engineered to simplify diagnostic testing while ensuring speed, accuracy and performance."