Drawbridge Health received 510(k) clearance from the Food and Drug Administration for its’ OneDraw A1C Test System on Aug. 22.
The test system includes the OneDraw Blood Collection Device and the OneDraw A1C Test. The Blood Collection Device allows health care professionals to safely and comfortably draw blood from patients who need to monitor their A1C levels. The device is different from other testers which use a hypodermic needle because it uses tiny lancets with a light vacuum suction to collect the blood.
"Patients hate being stuck with needles and many will avoid important testing at all costs. Based on my experience, I believe my patients will be much more comfortable and relaxed – minimal pain and they can't see the blood," said Kristin Castorino, D.O., Sansum Diabetes Research Institute.
The 510(k) clearance was granted after extensive positive clinical data presented at the 2019 ADA Annual Conference and a patient’s preference for the device over a traditional fingerstick.
"Drawbridge Health was founded with the vision and intent to categorically and positively change the nature of blood-based diagnostic testing, improving both the collection process and patient experience," said Lee McCracken, CEO at Drawbridge Health. "Our 510(k) clearance is a critical milestone as we make our founding vision a reality. We look forward to making our novel technology commercially available soon."
