Becton Dickinson (BD) received 510(k) clearances from the U.S. Food and Drug Administration (FDA) for its new sample collection device system that pulls blood from a fingerstick to enable common blood tests without the need for a phlebotomist, the company announced.
The blood collection system consists of a capillary blood collection tube and a finger sleeve. Called the BDMiniDraw Capillary Blood Collection System, the single-use noninvasive device requires accessories and appropriate finger fit, and is intended for use on individuals 18 years and older.
“The 510(k) clearances include low-volume blood collection for a lipid panel, selected chemistry tests, and hemoglobin and hematocrit (H&H) testing,” BD said. “These tests are among the most commonly ordered lab tests and can be used to diagnose and monitor a variety of chronic conditions from hypertension to high cholesterol.”
The blood collection system is intended for use by trained healthcare workers in ancillary healthcare facilities such as retail pharmacies and clinics, as well as clinical and laboratory use environments.