OneTouch Verio® – System Accuracy
Products
OT Verio Meter
System Accuracy:
System Accuracy Results for Glucose Concentrations <75 mg/dL:
System Accuracy Results for Glucose Concentrations ≥75 mg/dL:
System Accuracy Results across the entire Glucose Range:
Fingertip Results for Glucose Concentrations <75 mg/dL:
Fingertip Results for Glucose Concentrations ≥75 mg/dL:
Regression Statistics:
Precision:
- Diabetes experts have suggested that glucose meters should agree within 15 mg/dL of a laboratory method when the glucose concentration is lower than 75 mg/dL, and within 20% of a laboratory method when the glucose concentration is ≥75 mg/dL or higher. Samples from 100 patients were tested using both the OneTouch Verio® System and the YSI 2300 Glucose Analyzer laboratory instrument.
System Accuracy Results for Glucose Concentrations <75 mg/dL:
- Percent (and number) of meter results that match the laboratory test:
System Accuracy Results for Glucose Concentrations ≥75 mg/dL:
- Percent (and number) of meter results that match the laboratory test:
System Accuracy Results across the entire Glucose Range:
- Percent (and number) of meter results that match the laboratory test:
- Therefore, 100% of the total results obtained with the OneTouch Verio® System achieved the goal suggested by the diabetes experts.
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 in duplicate on each of three test strip lots. Results indicate that the OneTouch Verio® System compares well with a laboratory method.
Precision:
- Within Run Precision (300 Venous Blood Tests per Glucose Level)
- Results show that the greatest variability observed between test strips when tested with blood is 2.44% or less.
- Total Precision (200 Control Solution Tests per Glucose Level)
AW 06908604A
