Information regarding system accuracy for the OneTouch Select Plus Simple® meter.
Product Guide
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OneTouch Select Plus Simple® meter
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System Accuracy:
Diabetes experts have suggested that glucose meters should agree within 15 mg/dL of a laboratory method when the glucose concentration is lower than 100 mg/dL, and within 15% of a laboratory method when the glucose concentration is 100 mg/dL or higher. Samples from 100 patients were tested using both the OneTouch Select Plus Simple® System and the YSI 2300 Glucose Analyzer laboratory instrument.
System Accuracy Results for Glucose Concentrations <100 mg/dL
Percent (and number) of meter results that match the laboratory test
System Accuracy Results for Glucose Concentrations ≥100 mg/dL
Percent (and number) of meter results that match the laboratory test
System Accuracy Results for Glucose Concentrations Between 39.9 mg/dL and 451 mg/dL
Percent (and number) of meter results that match the laboratory test
NOTE: Where 39.9 mg/dL represents the lowest glucose reference value and 451 mg/dL represents the highest glucose reference value (YSI value).
User Performance Accuracy:
A study evaluating glucose values from fingertip capillary blood samples obtained by 160 lay persons showed the following results:
96.6% within ±15 mg/dL of the medical laboratory values at glucose concentrations below 100 mg/dL, and
94.7% within ±15% of the medical laboratory values at glucose concentrations at or above 100 mg/dL.
95.0% of the total number of samples were within ±15 mg/dL or ±15% of the medical laboratory values.
Regression Statistics:
Samples were tested in duplicate on each of three test strip lots. Results indicate that the OneTouch Select Plus Simple® System compares well with a laboratory method.
Precision:
Within Run Precision (300 Venous Blood Samples Tested per Glucose Level)
Data generated using the OneTouch Select Plus Simple® Meter.
Results show that the greatest variability observed between test strips when tested with blood is 2.11 mg/dL SD or less at glucose levels less than 100 mg/dL, or 2.61% CV or less at glucose levels at 100 mg/dL or above.
Total Precision (600 Control Solution Tests per Glucose Level)
Data generated using the OneTouch Select Plus Simple® Meter.
