FDA OKs Beckman Coulter’s DxC 500i Clinical Analyzer

Beckman Coulter Diagnostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its DxC 500i clinical analyzer, an integrated clinical chemistry and immunoassay analyzer.

DxC 500i merges advanced tech with an intuitive user interface so labs of all sizes can meet modern healthcare’s growing demands. It has a throughput of up to 800 clinical chemistry tests per hour and 100 immunoassay tests per hour.

The analyzer features FlexMode operations that prioritize immunoassay and chemistry testing according to each sample’s urgency. Its new dynamic sample handler manages repeats and re-runs without operator intervention and pulls in a new sample rack as soon as the prior rack is offloaded.

The clinical analyzer has been available in CE mark-accepted countries since July 2024.

“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,” said Kathleen Orland, Chief Portfolio Officer for Beckman Coulter Diagnostics. “Beyond ensuring appropriate throughput levels for a networked lab, Beckman Coulter’s common reagents and consumables across its scalable clinical chemistry and immunoassay portfolio enables common reference ranges, offering IDNs strategic benefits in patient care and inventory management.”

In January, Beckman Coulter gained FDA breakthrough status for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio, a blood test to help identify patients with amyloid pathology associated with Alzheimer’s disease.