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.
