Medical technology firm Becton, Dickinson and Company (BD) has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its FACSPresto system and FACSPresto CD4/Hb Cartridge.
The BD FACSPresto system is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer, which offers absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples to manage HIV/AIDS patients.
BD biosciences worldwide president Claude Dartiguelongue said: "This FDA 510(k) clearance aligns with BD’s purpose of advancing the world of health.
"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."
Weighing around 6kg, the system will use a proprietary dried reagents cartridge to provide increased stability across a wide range of storage conditions.
The system, which features touchscreen and language-independent user interface, can process up to 80 tests in a normal day.
After finger stick or venipuncture blood collection, the process involves transfer and incubation of sample on a single-use disposable cartridge. The results will be provided within four minutes.
BD provides solutions to advance medical research and genomics, enhance the diagnosis of infectious disease and cancer and improve medication management.
Image: Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. Photo: courtesy of C. Goldsmith.