NEW YORK – Danaher subsidiary Beckman Coulter Diagnostics announced on Monday that its integrated clinical chemistry and immunoassay analyzer has received 510(k) clearance from the US Food and Drug Administration.
The DxC 500i Clinical Analyzer has a throughput of up to 800 clinical chemistry tests and 100 immunoassays per hour. It also features FlexMode, which prioritizes immunoassay and chemistry testing according to each sample's urgency, and it has a new sample handler to manage repeats and re-runs without operator intervention, Beckman Coulter said in a statement.
The DxC 500i has been available in countries accepting the CE mark since July.
"Innovations like the DxC 500i Clinical Analyzer enable Beckman Coulter to address the needs of networked laboratories with specific solutions for satellite or independent laboratories, as well as core laboratories," Beckman Coulter Diagnostics Chief Portfolio Officer Kathleen Orland said in a statement.
The analyzer incorporates the technology from Beckman's automated DxC 500 AU Chemistry Analyzer within its clinical chemistry capabilities, the company noted. It uses Beckman Coulter's reagents and consumables across the firm's immunoassay and clinical chemistry portfolio.