BD awarded FDA 510(k) clearance for blood collection device
The BD MiniDraw™ Capillary Blood Collection System enables lab-quality testing in convenient locations for patients, such as local pharmacies
FRANKLIN LAKES, N.J. — Becton, Dickinson and Company (BD), a global medical technology company, recently received 510(k) clearance from the FDA for the BD MiniDraw™ Capillary Blood Collection System, a new device which enables blood sample collection from a fingerstick, producing lab-quality results for commonly ordered blood tests.
The BD MiniDraw™ System offers a less invasive alternative to traditional venous blood draws, using 16-18 drops of capillary blood from a patient’s fingertip to achieve accurate test results. The device is designed for use by trained healthcare workers, which will allow it to be utilized in locations such as retail pharmacies, a benefit to patients who may not have the ability or means to get to a commercial lab.
The FDA’s 510(k) clearances cover the system’s use for collecting small volumes of blood needed for a lipid panel, selected chemistry tests, and hemoglobin and hematocrit (H&H) testing, which are critical for diagnosing and monitoring conditions like hypertension, high cholesterol and others.
“Because the BD MiniDraw™ Collection System enables blood collection at non-traditional sites that may be more convenient – like your local pharmacy rather than a standalone lab – we can expand health equity and access, and make it easier for patients to get the blood tests they need both for preventative care and the management of chronic conditions,” said Dave Hickey, executive vice president and president of Life Sciences for BD. “This innovation is our strategy and pipeline coming to life, and proof of our commitment to enabling diagnostics and care in alternate settings.”
The BD MiniDraw™ Collection System aims to simplify blood testing by enabling it in non-traditional settings, offering convenience and a potentially better patient experience. This approach may lead to improved patient adherence to testing, earlier diagnosis and better chronic condition monitoring.
“Consumers want more convenience, a better experience and to take more control over their health,” said Bridget Bagnato, worldwide president of specimen management for BD. “We believe the BD MiniDraw™ Collection System is potentially a game-changing innovation that combines convenience and better patient experience with lab-quality results.”
Learn more about the BD MiniDraw™ Capillary Blood Collection System on the BD website.