BD Gets FDA 510(k) Clearance For Fingertip Blood Collection Device
(RTTNews) - Medical technology company Becton, Dickinson and Co. or BD (BDX) announced Thursday it has received 510(k) clearances from the U.S. Federal Drug Administration (FDA) for a novel blood collection device that obtains blood samples from a fingerstick that produce lab-quality results for some of the most commonly ordered blood tests.
The BD MiniDraw Capillary Blood Collection System is less invasive than a traditional venous blood draw by using capillary blood collected from a patient's finger by a trained healthcare worker, without the need for a phlebotomist to collect blood from a vein.
The innovative design provides a sample that produces lab-quality blood test results from a fraction of the volume of traditional venous collections. It is less invasive than traditional venous blood collection methods and more convenient for the patient by expanding access to blood collection to new locations, including retail pharmacies.
The device may provide a better patient experience and has the potential to transform diagnostic testing.
The 510(k) clearances include low-volume blood collection for a lipid panel, selected chemistry tests, and hemoglobin and hematocrit (H&H) testing. BD plans to expand blood tests enabled by BD MiniDraw Collection System in the future.
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