Devices Diagnostics HIV/AIDS FDA

 News Release - February 10, 2016

BD Receives FDA 510(k) Clearance for Diagnostic Device for HIV/AIDS

Expands Flow Cytometry Portfolio with BD FACSPresto™ System

FRANKLIN LAKES, N.J., Feb. 10, 2016 -- (Healthcare Sales & Marketing Network) -- BD (Becton, Dickinson and Company) (BDX), a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its BD FACSPresto™ system and BD FACSPresto™ CD4/Hb Cartridge.

The BD FACSPresto system is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to manage HIV/AIDS patients.

"This FDA 510(k) clearance aligns with BD's purpose of advancing the world of health," said Claude Dartiguelongue, worldwide president for Biosciences at BD. "We believe our BD FACSPresto system provides superior ability to accurately monitor patients living with HIV/AIDS in a variety of health care settings at a reasonable cost, which ultimately may help control the spread of the disease."

BD designed the system as an intuitive, easy-to-use instrument, weighing only 6 kg (13.23 lb.) and using a proprietary dried reagents cartridge to offer increased stability across a wide range of storage conditions. The system includes a touchscreen, language-independent user interface and is able to process up to 80 tests in a normal day. After finger stick or venipuncture blood collection, it is a simple process to transfer and incubate the sample on a single-use disposable cartridge with results available in less than four minutes.

Results from clinical studiesi demonstrate that the BD FACSPresto system performs comparably with traditional analyzers, including the BD FACSCalibur™ system, for accuracy, precision, and linearity across a wide measuring range.

About BD

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. BD leads in patient and health care worker safety and the technologies that enable medical research and clinical laboratories. The company provides innovative solutions that help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. The company partners with organizations around the world to address some of the most challenging global health issues. BD has more than 45,000 associates across 50 countries who work in close collaboration with customers and partners to help enhance outcomes, lower health care delivery costs, increase efficiencies, improve health care safety and expand access to health. For more information on BD, please visit bd.com.

i Data on file at BD

Source: Becton, Dickinson

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