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Classified in: Health
Subject: FDA

Beckman Coulter's Compact, Low-volume Hematology Analyzer Receives FDA 510(k) Clearance


BREA, Calif., March 21, 2019 /PRNewswire/ -- Beckman Coulter, a global leader in clinical diagnostics, announced today that its DxH 520 hematology analyzer has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and is now available for sale in the United States. Designed for low-volume laboratories including clinics and physician offices, the DxH 520 features unique technology that improves sample flagging by 40%*, ensuring better first-pass yield and accurate differentials with as little as 17 microliters of blood. Delivering accurate, rapid and reliable results with such a small drop of blood makes the DxH 520 ideal for neonate, pediatric, and critical-care patients who are only able to provide a small sample.

Beckman Coulter's compact, low-volume hematology analyzer, the DxH 520

"Laboratories are under increased pressure to deliver high-quality results while improving operational efficiency," said Peter Soltani, Ph.D., senior vice president and general manager of hematology at Beckman Coulter. "The analytical strengths and data management capabilities of the DxH 520 make it a powerhouse analyzer that delivers the right results, the first time. Combined with the ease of use and small footprint of a tabletop system, the system also helps to drive down costs and increase productivity by automating operational tasks, enabling laboratory technologists to free up time for more critical tasks."

The DxH 520's closed tube aspiration capability reduces manual steps and ensures safety for laboratorians by eliminating sample exposure and risk of contact with blood-borne pathogens. Additionally, the analyzer features a robust patient data and quality control (QC) management package that enables users to access any screen within three touches or less, reducing clerical errors and improving operational efficiency. The QC management system also allows for easy retrieval from a vast storage database of up to 30,000 patient samples?or over 16 months of clinical data in heavy-use scenarios.

The DxH 520's two environmentally friendly reagents and on-board cleaner can be replaced in five minutes or less. In addition, its reagents are water-based and cyanide-, azide- and formaldehyde-free. This approach eliminates the disposal costs associated with competitive systems that employ multiple reagents and/or harsh solvents.

Key features of the DxH 520 include:

Beckman Coulter's DxH 520 builds on the organization's strength in hematology innovation and complements its broad spectrum of hematology analyzers, including the DxH 600 for mid-volume, DxH 900 for large-volume and DxH connected workcell solutions for ultra-high-volume facilities. For more information on the DxH 520, please visit http://beckmancoulter.com/DxH520 or check out the video.

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.

*when compared to fixed gating technology.

© 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.

 

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

SOURCE Beckman Coulter


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News published on 21 march 2019 at 08:00 and distributed by: