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OneTouch Ultra Plus Flex™ - Lay User Accuracy, Regression Statistics And Precision

Published 2025-03-26
Updated 2025-03-31
Products OT Ultra Plus Flex Meter
Lay User Accuracy:
  • User Accuracy of the system was assessed at 4 clinical sites. 169 patients tested their blood using the OneTouch Ultra Plus 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 Ultra Plus 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 Ultra Plus Flex™ Meter.
  • Results show that the greatest variability observed between test strips when tested with blood is 0.86 mg/dL SD or less at glucose levels less than 75 mg/dL or 2.13% 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 Ultra Plus Flex™ Meter.
 

AW 07295104 B