OneTouch Verio Flex^® – Lay User Accuracy

Lay User Accuracy:

• User Accuracy of the system was assessed at 3 clinical sites. 172 patients tested their blood using the OneTouch Verio Flex^® System where results were compared to the YSI 2300 Glucose Analyzer laboratory Instrument.

 Fingertip Results for Glucose Concentrations <75 mg/dL:

• Percent (and number) of meter results that match the laboratory test.

 

Fingertip Results for Glucose Concentrations ≥75 mg/dL:

• Percent (and number) of meter results that match the laboratory test.

Regression Statistics:

• Samples were tested on each of three test strip lots. Results indicate that the OneTouch Verio Flex^® System compares well with a laboratory method.

Precision:

• Within Run Precision (300 Venous Blood Samples Tested per Glucose Level).
  • Data generated using the OneTouch Verio Flex^® Meter.

• Results show that the greatest variability observed between test strips when tested with blood is 0.83 mg/dL SD or less at glucose levels less than 75 mg/dL or 1.98% CV or less at glucose levels at 75 mg/dL or above.

• Total Precision (600 Control Solution Tests per Glucose Level).
  • Data generated using the OneTouch Verio Flex^® Meter.