Therapy Areas: Diabetes
Drawbridge Health wins FDA 510(k) clearance for OneDraw A1C Test System for monitoring glucose control
23 August 2019 -

Healthcare company Drawbridge Health reported on Thursday the receipt of US Food and Drug Administration (FDA) 510(k) clearance for its OneDraw A1C Test System for monitoring the long-term control of blood sugar (glucose) in people with diabetes.

The OneDraw A1C Test System, which is comprised of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended for the collection and stabilisation of blood and measurement of HbA1c levels. It enables blood to be drawn quickly, comfortably and conveniently by a healthcare professional.

According to the company, the OneDraw Blood Collection Device is a small, single-use device that draws, collects and stabilises a capillary blood sample from the upper arm. The device is placed on the skin and blood is gently collected using tiny lancets with a light vacuum suction. The blood sample is then stabilised and contained within a removable cartridge, designed to protect the sample during transport.

Following the use of the OneDraw Blood Collection Device, the OneDraw A1C Test is performed by a designated certified clinical laboratory.

Based on the company's positive clinical data, the results showed a strong correlation in the HbA1c measurement obtained from samples collected using the OneDraw Blood Collection Device and those using venipuncture as well as a marked patient preference for the OneDraw Blood Collection device compared to venipuncture or fingerstick.

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