Beckman Coulter’s receives FDA clearance

Beckman Coulter’s DxH 520 hematology analyzer has received 510(k) clearance from the US 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 percent, ensuring better first-pass yield and accurate differentials with as little as 17 microliter 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 able to provide only a small sample. 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 environment-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.