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

With just 17 microliters of blood, the DxH 520 enables low-volume laboratories to deliver 5-part differential test results in 60 seconds or less

BREA, Calif. — (March 21, 2019) — 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.

“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: • 5-part differential testing in a compact and cost-effective package • Small sample volume requirement, well suited to patients with difficult blood draws • Only three screen touches to access any menu • Environmentally friendly reagents for cost-effective, easy waste disposal • Closed tube analyzer for enhanced safety

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 or check out the video.