PERFORMANCE EVALUATIONS:

Precision

1. Laboratory Precision: To assess the repeatability (within-run precision) of Ascensia® BREEZE ™, 100 blood glucose readings (10 readings on each of 10 instruments) were obtained with venous blood specimens at five glucose concentrations. The following table summarizes the mean and pooled within-meter %CV at each level.

Mean

2.9 mmol/L

7.4 mmol/L

9.1 mmol/L

14.7 mmol/L

23.7 mmol/L

%CV

8.9%

4.1%

4.4%

3.8%

2.9%

 

 

 

 

 

 

2. Control Testing Precision: An imprecision study of the Ascensia® BREEZE ™ System was conducted at two diabetes clinics. In each location, 50 lay persons with diabetes tested the low, normal and high control solutions in duplicate using the meter system. A different lot of test strips was used in each of the two locations. The table below shows the total standard deviations (SD) and coefficients of variation (CV), which include the within run and between run / day variations.

Low Control Solution

 

 

 

 

Total

Total

Strip

 

No. of

Mean

SD

CV

Lot

Operator

Assays

(mmol/L)

(mmol/L)

(%)

A

Lay User (n=50)

100

4.272

0.267

6.2

B

Lay User (n=50)

100

4.100

0.244

6.0

 

 

 

 

 

 

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