Animas OneTouch Ping Owner's Booklet page 189

CHAPTER 11 - DETAILED INFORMATION ABOUT YOUR METER REMOTE AND TEST STRIPS
Analytical Performance Characteristics
System Accuracy
The accuracy of the blood glucose monitoring function of the OneTouch
assessed by comparing blood glucose test results on 141 subjects with those obtained using a YSI
Model 2300 Glucose Analyzer. Six results were obtained for each subject (each tested in duplicate
with three test strip lots). The following results were obtained:
System Accuracy Results for Glucose Concentration <75 mg/dL
Within ±5 mg/dL
111/162 (68.5%)
System Accuracy Results for Glucose Concentration 75 mg/dL
Within ±5%
282/684 (41.2%)
System Accuracy Results across the entire Glucose Range
Within ±15 mg/dL or ±20%
These results indicate that the blood glucose monitoring function of the OneTouch
meets the ISO 15197 requirements for accuracy.
* ISO 15197 Minimum Acceptable Accuracy Requirements:
• 95% of individual glucose results must fall within ±15 mg/dL of the YSI reference at glucose
concentrations <75 mg/dL
• 95% of individual glucose results must fall within ±20% of the YSI reference at glucose
concentrations 75 mg/dL
Regression Statistics
# of # of
Subjects Readings
141 846
These results indicate that the OneTouch
Abbreviations:
CI Confidence Interval
S Standard Error
y.x
Within ±10 mg/dL
154/162 (95.1%)
Within ±10%
516/684 (75.4%)
842/846 (99.5%)
Slope Intercept
(mg/dL) (mg/dL)
0.988 -3.68 (0.98, 1.00) (-5.54,-1.81)
® Ping ™ Meter Remote compares well with a laboratory method.
Std. Standard
R 2 Coefficient of Determination
173
® Ping ™ Meter Remote was
Within ±15 mg/dL*
162/162 (100%)
Within ±15%
639/684 (93.4%)
95% CI 95% CI
Slope Intercept
Within ±20%*
680/684 (99.4%)
® Ping ™ Meter Remote
2
Std. Error R
(S )
y.x
14.3 0.984