The Food and Drug Administration (FDA) has granted 510(k) market clearance to the OneDraw A1C Test system, which monitors HbA1c levels in individuals with diabetes for long-term glucose control.

The system includes the OneDraw Blood Collection Device and the OneDraw A1C Test to measure HbA1c levels. The single-use device uses tiny lancets with a vacuum suction to draw, collect and stabilize a capillary blood sample from the upper arm. The sample is contained in a removable cartridge, which is processed by a designated certified clinical laboratory using the OneDraw A1C Test. 

A study of the device in 146 participants found a correlation between the device and venipuncture for HbA1c values between 4.91 and 13.34% (y=1.01-0.0131, R2=0.997). Device lot-to-lot and operator-to-operator reproducibility studies showed CVs of 0.7% and 0.8%, respectively.

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“I believe my patients will be much more comfortable and relaxed [with the new device] – minimal pain and they can’t see the blood,” said Kristin Castorino, DO, Sansum Diabetes Research Institute. 

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