Beckman Coulter's DxA 5000 Laboratory Automation Solution Receives FDA 510(k) Clearance

Beckman Coulter announced the DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is now available for sale in the United States. Launched in Europe earlier this year, the DxA 5000 with REMISOL Advance is improving automation for laboratories through a collection of patented innovations that deliver rapid and consistent turnaround time.

Beckman Coulter's DxA 5000 Laboratory Automation Solution Receives FDA 510(k) Clearance

Beckman Coulter’s DxA 5000

The DxA 5000 helps eliminate these preanalytical errors by automatically detecting patient tube parameters such as sample identification, tube type, orders pending and tube weight—all in the first three seconds. Designed with a focus on sample quality assessment, the system screens each sample at multiple points to help substantially reduce the risk of errors and alerts laboratorians if action is needed.

Based on research and work performed with Beckman Coulter's laboratory partners, manual sample processing steps are shown to make up approximately 70% of a laboratory's labor hours. The DxA 5000 significantly reduces the number of manual steps in sample processing, going from 32 steps to four. Moreover, the DxA 5000 utilizes Intelligent Routing to bring automated patient-centric workflow to the laboratory. By understanding the tests requested, sample volume available and real-time analyzer capacity and status, the DxA 5000 continuously calculates the most expeditious route for every patient sample—both STAT and routine.

"The DxA 5000 is a key component of Beckman Coulter's vision that every laboratory should be able to harness the benefits of automation, no matter their size," said Julie Sawyer Montgomery, senior vice president of products and services & developed markets at Beckman Coulter. "This fundamental principle drives our solutions and innovation pipeline at Beckman Coulter. We are excited to launch the DxA 5000 into the U.S. market, and look forward to delivering our full suite of automation solutions to laboratories of all sizes."

"We have seen a 17% improvement in turnaround time; improved on-time delivery of results for over 95% of our samples, and improved capacity of our tracks by 44%,” Dr. Maarten Kok, laboratory manager at Saltro, said.

"With intelligent sample routing we can take out problem samples at the beginning of the process, which gives us time to react appropriately,” Dr. Ralf Triepels from Bravis Hospital in the Netherlands said. “It is this feature that we found to be most unique about the DxA 5000. We were searching for a solution that would give us total process control, and help us make STAT samples history. Beckman Coulter delivered this opportunity for us. With the DxA 5000, we are delivering all results in less than 60 minutes."

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