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Subject: FDA

Beckman Coulter's DxA 5000 total laboratory automation solution receives U.S. FDA 510(k) clearance


BREA, Calif., Oct. 9, 2019 /PRNewswire/ -- Beckman Coulter, a global leader in clinical diagnostics, announced today that 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 already elevating automation for laboratories through a collection of patented innovations that deliver rapid and consistent turnaround time, provide a new level of comprehensive pre-analytical sample quality detection, and reduce the number of manual processing steps to significantly improve laboratory efficiency.

Beckman Coulter's DxA 5000 receives U.S. FDA 510(k) clearance

Delivering unmatched pre-analytical sample quality detection

Research shows errors that occur in the pre-analytical phase of testing may contribute up to 75% of erroneous test results, with 26% possibly having an adverse effect on patient care.1 Moreover, a vast majority of the factors causing erroneous results occur outside the laboratory, including inadequate volume, mislabeled samples and incorrect tube type.2,3,4,5

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 sharp 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.

Reducing manual processes and improving laboratory workflow

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 down to just 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."

Early adopters of the system have commented on the benefits of the DxA 5000:

Dr. Maarten Kok, laboratory manager at Saltro, a Diagnostic Center for Primary Care in the Netherlands, said that with the DxA 5000, "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. Ralf Triepels from Bravis Hospital in the Netherlands said, "With intelligent sample routing we can take out problem samples at the beginning of the process, which gives us time to react appropriately. 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."

Dr. Ram Doolman, director of the Automated Mega Laboratory and deputy director for the Laboratory Wing of the Medical Center and the Institute of Chemical Pathology at Sheba Medical Center, the largest hospital in Israel and the first DxA 5000 installation in the world said, "The staff is in love with the system. The DxA 5000 has removed many of the manual steps and is easy to use. You set the system up, you start it and you can forget it. Besides improving turnaround time by 25%, we have also managed to improve the usage of space. We went from two lines to one, which helped us free up half of our lab so we can now include microbiology, biochemistry and hematology all in one lab, together."

For more information on the DxA 5000 or Beckman Coulter's full suite of automation solutions, please visit BeckmanCoulter.com/DxA.

About Beckman Coulter
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory's role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

1 Green. Sol. F., Clinical Biochemistry 46 (2013), 1175?1179.
2J Clin Diagn Res, Nov; 7(11): 2491?2493. 2013.
3 LabMedicine, 41, 89-92. (2010).
4 Clinical Chemistry 53:7, 1338?1342 (2007).
5 DOI 10.1515/cclm-2013-0597. Clin Chem Lab Med 2013; aop.

© 2019 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. REMISOL Advance is a trademark or registered trademark of Normand-Info SAS in the United States and other countries. Used under license.

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

SOURCE Beckman Coulter


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