NEW YORK – Drawbridge Health announced today it has received 510(k) clearance from the US Food and Drug Administration for its OneDraw A1C Test System, which includes a blood collection device and HbA1c test.
The Menlo Park, California-based company developed the OneDraw Blood Collection Device to replace traditional needle or fingerstick blood draws. Instead, the device is placed on the upper arm and uses lancets to suction blood out of the arm and store it in a removable cartridge, making transportation of samples easier.
Once the sample has been collected, the OneDraw A1C Test is used by a clinical lab to check HbA1c levels to monitor glucose in diabetic patients.
Many patients avoid necessary blood tests due to fear of needles or distaste for blood, the company said, so the device is meant to ease those worries and ensure patients receive the blood work they need.
Drawbridge Health's goal is to make it easier and more comfortable for patients to get blood drawn. The company said it hopes to make the OneDraw system commercially available soon.
Drawbridge previously announced a partnership with Thorne Research to commercially distribute its products in the US.