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Beckman Coulter Chemistry Analyzer Receives FDA Clearance

NEW YORK (360Dx) – The US Food and Drug Administration has granted 510(k) clearance to the Beckman Coulter Diagnostics DxC 700 AU chemistry analyzer, the firm said today.

Beckman has launched the new system in the US and will make it available in other regions of the world this year.

The system combines "the simple intuitive design" of the firm's DxC analyzer and "robust throughput and workhorse capabilities" of its AU analyzer into a standard platform designed to meet the needs of mid- to high-volume clinical laboratories, the firm said.

“In today’s changing healthcare climate, laboratories are asked to elevate care and to reduce costs,” John Blackwood, senior vice president of chemistry and immunoassay at Beckman Coulter Diagnostics, said in a statement. He noted that with the DxC 700 AU analyzer, the firm has combined 'two time-proven technologies."

Additional features and benefits were identified and designed into the product by gathering input from clinical laboratory professionals, he added.

Features include "powerful operating software, an all-new design, and an intuitive user-interface that allows operators to spend less time on daily tasks and more time producing the quality results that empower better decision-making for better patient care," the firm said, and added that the new chemistry analyzer reduces the number of test-processing steps by 30 percent, streamlining workflow for laboratory professionals.

The analyzer also reduces total cost of ownership for hospital laboratories and integrated delivery networks by using fewer consumables than other systems in the same class, Beckman said.