FDA grants 510(k) clearance for Drawbridge Health’s OneDraw test system

23 August 2019 (Last Updated August 23rd, 2019 13:55)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Drawbridge Health’s OneDraw A1C Test System.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Drawbridge Health’s OneDraw A1C Test System.

The OneDraw A1C Test System aims to collect and stabilise blood and measurement of HbA1c levels to monitor long-term control of blood sugar (glucose) in those with diabetes.

A healthcare professional (HCP) can use OneDraw to draw blood quickly and comfortably.

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.”

The small, single-use OneDraw Blood Collection Device collects and stabilises a capillary blood sample from the upper arm.

It can be placed on the skin to collect blood gently using tiny lancets with light vacuum suction. The blood sample is then stabilised and contained within a removable cartridge.

A designated certified clinical laboratory performs the OneDraw A1C Test after use of the OneDraw Blood Collection Device.

Additionally, the OneDraw Blood Collection Device optimises the blood collection process for the patient and enables conducting blood sampling anywhere.

The 510(k) clearance for the device comes after the company presented positive clinical trial data.

The data results highlighted a strong correlation in the HbA1c measurement obtained from samples collected using the OneDraw Blood Collection Device and those using venipuncture.