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OneTouch Verio® Test Strips - Performance, Accuracy, and Statistics:
- In vitro diagnostic. For self-testing.
- Important:
- Please read this insert and your User Guide or Owner's Booklet before using. The User Guide or Owner's Booklet has full instructions for blood glucose and control solution testing.
- Do Not use new test strips if the vial is open or damaged in any way. This could lead to error messages or inaccurate blood glucose results.
- Contact OneTouch® Customer Care right away if you have questions about your test strips, test results or these instructions.
- Refer to your User Guide or Owner's Booklet for important information about cleaning and disinfecting your meter, lancing device, and caps.
- The meter and lancing device are for single patient use. Do Not share them with anyone including other family members! Do Not use on multiple patients! All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
- WARNING: Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or other bloodborne pathogens.
Performance Characteristics:
- The performance of the OneTouch Verio® Test Strip has been evaluated both in laboratory and in clinical tests.
- Measurement range:
- The measurement range of the OneTouch Verio® Family of Meters is 20 to 600 mg/dL.
- The following data is representative of the OneTouch Verio® Family of Meters except the OneTouch Verio Reflect® Meter. Refer to your system Owner's Booklet for performance data specific to your system.
- System Accuracy:
- Samples from 100 patients were tested using both the OneTouch Verio® System and the YSI 2300 Glucose Analyzer laboratory instrument.
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- System Accuracy Results for Glucose Concentrations <75 mg/dL:
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- Percent (and number) of meter results that match the laboratory test.
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- System Accuracy Results for Glucose Concentrations ≥75 mg/dL:
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- Percent (and number) of meter results that match the laboratory test.
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- System Accuracy Results across the entire Glucose Range
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- 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® System compares well with a laboratory method.
- Precision:
- Within Run Precision (300 Venous Blood Tests per glucose level)
- Data generated using the OmniPod® Insulin Management System.
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- Results show that the greatest variability observed between test strips when tested with blood is 2.65% or less.
- Total Precision (600 Control Solution Tests per glucose level)
- Data generated using the OneTouch Verio IQ® Meter.
- The following data is representative of the OneTouch Verio Reflect® Meter:
- Your OneTouch Verio Reflect® Meter result may vary slightly from your actual blood glucose value. This may be due to slight differences in technique and the natural variation in the test technology.
- The chart below shows the results of a study where 354 typical users used the OneTouch Verio Reflect® Meter to test their blood glucose level. For example, in this study, the OneTouch Verio Reflect® Meter gave results within 15% of their true blood glucose level 351 out of 354 times.
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- Regression Statistics:
- Samples were tested on one of three test strip lots. Results indicate that the OneTouch Verio Reflect® System compares well with a laboratory method.
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- Precision:
- Within Run Precision (300 Venous Blood Tests per glucose level)
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- Data generated using the OneTouch Verio Reflect® Meter show that the greatest variability observed between test strips from three strip lots when tested with blood is 1.05 mg/dL SD or less at glucose levels less than 75 mg/dL or 3.07% 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 Reflect® Meter.
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