Ascensia CONTOUR Result (mmol/L)

30

y=x

25

20

15

10

5

0

0

5

10

15

20

25

30

YSI Plasma Glucose Result (mmol/L)

Passing and Bablok Regression Statistics / Pearson correlation

 

 

95% Confidence Interval

 

n

y =

Slope

/

Intercept

r

746

1.01x – 0.49

1.00 to 1.03

 

–0.58 to –0.39

0.992

2. Professional / Lay User Evaluation

A Patient Use evaluation was conducted at two diabetes clinics. Lay users with diabetes were given product instructions with no training. After reviewing the instructions, the users performed fingersticks and glucose assays using the Ascensia™ CONTOUR ™ System. Two reagent lots were evaluated at each clinic; one was common to both sites. After the user’s self test, the attending HCP performed Ascensia CONTOUR System assays from the lay user’s

25