The OneDraw A1C Test System was granted marketing clearance based on the strength of clinical findings reported at ADA 2019.
The US Food and Drug Administration (FDA) has granted 510(k) clearance for the OneDraw A1C Test System, a blood collection and HbA1c measurement device indicated for patients with diabetes.
The test system from Drawbridge Health is designed to monitor long-term glucose control in diabetics. It’s comprised of the OneDraw brand’s AC1 test system and blood collection device. The device’s intended use in practice is for healthcare professionals.
The device includes a series of miniature lancets with a light vacuum suction which draws patients’ blood in a more easing manner than traditional hypodermic needles. The blood is then stabilized in a removable cartridge container. The A1C test is later performed by a designated, certified clinical laboratory.
The FDA 510(k) clearance was granted following the presentation of positive clinical data at the American Diabetes Association (ADA) 2019 Scientific Sessions in June this year. The data showed a strong correlation in the HbA1c measurement collected from the device samples and samples collected using venipuncture. The findings also indicated a notable patient preference for the OneDraw Blood Collection device versus the options of venipuncture or fingerstick.
Kristin Castorino, DO, of the Sansum Diabetes Research Institute, commented that her patients will frequently avoid testing for the sake of not having blood drawn with needles.
“Based on my experience, I believe my patients will be much more comfortable and relaxed—minimal pain and they can't see the blood," she said in a statement.
Lee McCracken, chief executive officer at Drawbridge Health, added a tentative release date for the device in his statement.
"Our 510(k) clearance is a critical milestone as we make our founding vision a reality,” McCracken said in a statement. “We look forward to making our novel technology commercially available soon."