BD said it has received 510(k) clearances from the 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 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. 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. BD plans to expand blood tests enabled by BD MiniDraw Collection System in the future.
Traditionally when a patient requires "blood work," a doctor orders the test, and an appointment is made at a laboratory service center where a nurse or phlebotomist draws tubes of blood from the patient's vein. The BD MiniDraw™ Collection System has the potential to transform this experience by expanding blood testing to new, more convenient settings, which can benefit patients, health care providers and collection sites.
For patients, capillary collection with the BD MiniDraw Collection System provides the convenience of having blood drawn somewhere they already frequent, like a retail pharmacy or grocery store, which may have longer hours of operation and be closer to where they live or work. For these non-traditional collection sites, it enables expansion beyond existing health and wellness programs like administering vaccinations and can generate additional store traffic.
