Clearance Granted to New HbA1c Test Device

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.

“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. 

For more information visit Drawbridge.com.