OneTouch Ultra Plus™ Test Strips:
- 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 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 infectious or potentially infectious 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 Ultra Plus™ Test Strip has been evaluated both in laboratory and in clinical tests.
- Measurement Range: The measurement range of the OneTouch Ultra Plus Flex™ Meter is 20 to 600 mg/dL.
- The following data is representative of the OneTouch Ultra Plus Flex™ Meter. Refer to your system Owner's Booklet for performance data specific to your 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 75 mg/dL, and within 20% of a laboratory method when the glucose concentration is 75 mg/dL or higher. 169 patients tested their blood using the OneTouch Ultra Plus Flex™ System where the results were compared to the the YSI 2300 Glucose Analyzer laboratory instrument.
- Accuracy Results for Glucose Concentrations <75 mg/dL
- Percent (and number) of meter results that match the laboratory test
- Accuracy 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 Tests per glucose level)
- Data generated using the OneTouch Ultra Plus Flex™ System.
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- Results show that the greatest variability observed between test strips when tested with blood is 2.46% or less.
- Total Precision (200 Control Solution Tests per glucose level)
- Data generated using the OneTouch Ultra Plus Flex™ Meter.
- IMPORTANT: For instructions, technical data and a list of symbols used, read your system User Guide or Owner's Booklet.
