BD Lands Clearance for Diagnostic Device for HIV/AIDS

The FDA has blessed BD with 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 concentration in whole blood samples to manage HIV/AIDS patients.

BD designed the system as an intuitive, easy-to-use instrument, weighing only 13.23 pounds and using a proprietary dried reagents cartridge to offer increased stability across a 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, the company said. — Jonathon Shacat