The OneDraw Blood Collection Device is a small, single-use device that draws, collects, and stabilises a capillary blood sample from the upper arm
Image: Drawbridge Health OneDraw A1C Test System. Photo: Courtesy of Drawbridge Health.
US-based healthcare technology firm Drawbridge Health has secured the United States Food and Drug Administration (FDA) 510(k) authorisation for its OneDraw A1C Test System that involves OneDraw Blood Collection Device and the OneDraw A1C Test.
The OneDraw A1C Test System is designed to offer blood collection, stabilisation and measurement of HbA1c levels for monitoring the control of blood glucose levels in diabetic patients.
Drawbridge said that its OneDraw A1C Test System allows health care professionals (HCP) to draw the blood sample quickly, comfortably, and conveniently.
Drawbridge Health CEO Lee McCracken said: “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. 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.”
OneDraw Blood Collection Device deploys tiny lancets to collect blood using light vacuum suction
The OneDraw Blood Collection Device, part of OneDraw A1C Test System, is a small, single-use device that draws, collects, and stabilises a capillary blood sample from the upper arm.
When placed on the skin, the device gently collects the blood using tiny lancets with a light vacuum suction, avoiding a traditional hypodermic needle to puncture a patient’s vein.
The collected blood is stabilised and stored within a removable cartridge, designed to protect the sample during transport. Following the use of OneDraw Blood Collection Device, the OneDraw A1C Test is carried out in a clinical laboratory.
Enabling blood sampling to be performed anywhere, the OneDraw Blood Collection Device optimises the blood collection process for both the patient and HCP. To provide convenience and comfort patients, particularly those suffering from the fear of needles, the company claims to have balanced thoughtful design and proprietary technology in making the device.
Drawbridge said that the FDA has granted 510(k) approval based on the positive clinical data from the study which indicated a strong correlation in the HbA1c measurement obtained from samples collected using the OneDraw Blood Collection Device and those using venipuncture.