Understanding system performance, precision, accuracy and statistics for the OneTouch Ultra® Test Strips.
Product Guide
USA
OneTouch Ultra® test strips
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OneTouch Ultra® Test Strips:
In vitro diagnostic. For self-testing.
Important:
Please read this information and your OneTouch Ultra® Family of Meters User Guide before using OneTouch Ultra® Test Strips.
Do Not use your OneTouch Ultra® Test Strips if your vial is open or damaged in any way as this could lead to error messages or inaccurate blood glucose values. Contact OneTouch® Customer Care immediately if the test strip vial is open or damaged, or if these instructional materials or your meter results seem unclear.
Performance Characteristics:
The performance of OneTouch Ultra® Test Strips has been evaluated both in laboratory and in clinical tests.
Measurement range:
The measurement range of the OneTouch Ultra® Family of Meters is 20 to 600 mg/dL (1.1–33.3 mmol/L).
System accuracy:
Diabetes experts have suggested that glucose meters should agree within 15 mg/dL (0.83 mmol/L) of a laboratory method when the glucose concentration is lower than 75 mg/dL (4.2 mmol/L), and within 20% of a laboratory method when the glucose concentration is 75 mg/dL (4.2 mmol/L) or higher. Samples from 100 diabetic patients at 1 clinical center were tested using both the OneTouch® Ultra® 2 System and the YSI Model 2300 Glucose Analyzer (laboratory test).
System Accuracy Results:
For Glucose Concentrations <75 mg/dL (4.2 mmol/L)
For Glucose Concentrations ≥75 mg/dL (4.2 mmol/L)
Across The Entire Glucose Range
Therefore, 96.3% of the total results obtained with the OneTouch® Ultra®2 System achieved the goal suggested by the diabetes experts.
Regression Statistics:
Samples were tested in duplicate on each of 3 test strip lots. Results indicate that the OneTouch® Ultra® 2 System compares well with a laboratory method.
Precision:
Within run precision (100 venous blood tests per glucose level)
Total precision (200 control solution tests per glucose level)
Results show that the greatest variability observed between test strips when tested with blood is 2.5% or less.
Data generated using OneTouch® Ultra® 2 Meter. OneTouch® Ultra® 2 is representative of the OneTouch Ultra® Family of Meters.
Important: For complete operating instructions and other important technical information, refer to the User Guide that came with your system. If you have questions about the use of any LifeScan product, please contact OneTouch® Customer Care.
