Beckman Coulter Announces FDA clearance of DxC 500i Clinical Analyzer, an integrated Clinical Chemistry and Immunoassay System

Core Insights - The new DxC 500i Clinical Analyzer from Beckman Coulter Diagnostics has received 510(k) clearance from the U.S. FDA, enhancing laboratory capabilities with advanced technology and user-friendly interface [1][2] - The analyzer can perform up to 800 clinical chemistry tests and 100 immunoassay tests per hour, providing precise results essential for clinical decision-making [1] Company Overview - Beckman Coulter Diagnostics is a leader in clinical diagnostics, focusing on improving patient health through innovative diagnostic solutions for over 90 years [7] - The company is part of Danaher Corporation, leveraging combined capabilities to enhance healthcare through advanced science and technology [8] Product Features - The DxC 500i features FlexMode operations, allowing prioritization of tests based on sample urgency, and includes a dynamic sample handler for optimized throughput [4] - It incorporates technology from the previously launched DxC 500 AU Chemistry Analyzer, ensuring high performance and standardized reagents across healthcare networks [5] Market Context - Approximately 45% of clinical laboratories in the U.S., totaling over 11,000 labs, are part of Integrated Delivery Networks (IDNs), which enhance resource management and quality of care [3] - Innovations like the DxC 500i are designed to meet the needs of networked laboratories, providing strategic benefits in patient care and inventory management [4]