27
SECTION
B
PERFORMANCE CHARACTERISTICS FOR CONSUMERS
Assure Platinum performance has been evaluated both in laboratory and clinical tests.
Diabetes experts have suggested that glucose meters should agree within 15 mg/dL of a
laboratory method and within 20% of a laboratory method when the glucose concentration is
75 mg/dL or higher. The chart below displays how often the Assure Platinum meter achieves
this goal. The chart is based on a study done to see how well the Assure Platinum blood
glucose meter compared to laboratory results.
Fingertip Results - Participant
For glucose results lower than 75 mg/dL, the percent (and
number) of meter results that match the laboratory method
within 15 mg/dL:
100%
6/6
For glucose results at 75 mg/dL or higher, the percent (and
number) of meter results that match the laboratory method
within 20%:
97%
92/95
Total number of patients in the study:
101
PERFORMANCE CHARACTERISTICS
FOR HEALTHCARE PROFESSIONALS
Precision
Precision results indicate that on average you can expect a 2.2% variation from back-to-back
testing across a 39 - 585 mg/dL glucose range. The table shows Coefficient of Variation
(CV%s) values for five glucose levels that cover the glucose range typical of persons with
diabetes. Values are averages for three separate lots of test strips.
Mean Glucose Level (mg/dL)
n
SD (mg/dL)
CV%
39
100
1.12
2.90
102
100
2.31
2.28
142
100
3.24
2.28
219
100
6.10
2.78
289
100
6.34
1.63
585
100
9.20
1.57
Accuracy
Assure Platinum was assessed against the YSI Model 2300. Studies were conducted by
Healthcare Professionals. The results below were obtained from subjects with Type 1
or Type 2 diabetes.
Assure Platinum
Professional
Slope
1.00
Y-Intercept
-2.33
Correlation coefficient
(r)
0.99
Number of subjects
288
Range tested (mg/dL)
26-480 mg/dL
The tables below show how well the Assure Platinum Blood Glucose Monitoring System
compared to the laboratory results.