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TROUBLESHOOTING AND DETAILED INFORMATION ABOUT YOUR SYSTEM
System Accuracy Results for Glucose Concentrations <4.2 mmol/L
Percent (and number) of meter results that match the laboratory test
Within ±0.28 mmol/L Within ±0.56 mmol/L Within ±0.83 mmol/L
56.1% (37/66) 89.4% (59/66) 98.5% (65/66)
System Accuracy Results for Glucose Concentrations ≥4.2 mmol/L
Percent (and number) of meter results that match the laboratory test
Within ±5% Within ±10% Within ±15% Within ±20%
38.2% (204/534) 71.7% (383/534) 89.5% (478/534) 97.9% (523/534)
System Accuracy Results across the entire Glucose Range
Percent (and number) of meter results that match the laboratory test
Therefore, 98% of the total results obtained with the OneTouch® Vita™ System
achieved the goal suggested by the diabetes experts.
Within ±0.83 mmol/L or ±20%
98.0% (588/600)
Regression Statistics
Samples were tested in duplicate on each
of three test strip lots. Results indicate that
the OneTouch® Vita™ System compares
well with a laboratory method.
95% CI Slope
95% CI
Intercept
(mmol/L)
Std. Error
(S
y.x
)
(mmol/L)
R
2
(1.020,
1.046)
(-0.742,
-0.449)
0.90449 0.977
Number of
Subjects
Number of
Tests
Slope Intercept
(mmol/L)
100 600 1.033 - 0.596