Ascensia® BREEZE ™ Plasma Glucose (mmol/L)
35
30
y=x
25
20
15
10
5
0
0 | 5 | 10 | 15 | 20 | 25 | 30 | 35 |
YSI Plasma Glucose (mmol/L)
|
| 95% Confidence Interval |
| ||
N | Y= | Slope | / | Intercept | R |
204 | 1.07x – 0.21 | 1.03 to 1.10 |
| 0.983 | |
|
|
|
|
|
|
2.Professional / Lay User Evaluation: A patient use evaluation was conducted at two diabetes clinics. Lay users with diabetes learned to use the meter system by reviewing the meter user guide. After reviewing the instructions, the users performed fingersticks and glucose assays using the Ascensia® BREEZE ™ System. Two test strip lots were evaluated, one at each of the two clinics. After the user’s self test, the attending healthcare professional performed an Ascensia® BREEZE ™ System assay from the lay user’s fingerstick. A capillary blood sample was then collected for
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