Bayer HealthCare Ascensia BREEZE and Ascensia AUTODISCTM Unique 10-Test Disc Accuracy, High Control Solution, Normal Control Solution, 1.Bayer Accuracy Evaluation:

Normal Control Solution

				Total	Total
Strip		No. of	Mean	SD	CV
Lot	Operator	Assays	(mmol/L)	(mmol/L)	(%)
A	Lay User (n=50)	100	8.394	0.400	4.8
B	Lay User (n=50)	100	8.317	0.356	4.3

High Control Solution

				Total	Total
Strip		No. of	Mean	SD	CV
Lot	Operator	Assays	(mmol/L)	(mmol/L)	(%)
A	Lay User (n=50)	100	18.706	0.961	5.1
B	Lay User (n=50)	100	18.867	0.800	4.2

Accuracy1.Bayer Accuracy Evaluation:

To assess the accuracy of the Ascensia® BREEZE ™ System, 102 fresh fingerstick specimens from people with diabetes were tested with the Ascensia® BREEZE ™ (2 readings per fingerstick) and the YSI 2300 STAT Plus Glucose Analyzer. The glucose concentration of the samples ranged from 2.3 to 30.1 mmol/L with an average of 9.9 mmol/L. The range of hematocrits was 29% to 55% with an average of 40%.

33