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ART05005 REV 4

Clarke Error Grid Analysis

Table 1 shows the distribution of the System/YSI data pairs within the zones of the

Clarke Error Grid. Overall, 98.2% of the pairs were within the clinically accurate A

Zone or the clinically acceptable B Zone of the error grid.

Table B.1: Clarke Error Grid Analysis of Data from FreeStyle Navigator

System Accuracy Study

Clarke Error Grid

Zone

Number of Pairs Percent Cumulative

Percent

A 7865 70.7 70.7

B 3056 27.5 98.2

C 36 0.3 98.5

D 165 1.5 100.0

E 0 0.0 100.0

Interfererents

In vitro and in vivo testing suggests that usual pharmacologic levels of ascorbic acid

have no effect on the function of the System but salicylic acid has minimal effect. In

vitro testing suggests that normal physiologic levels of uric acid, lipids, and bilirubin

do not affect System function. The impact of oral hypoglycemic agents and other

potential interfering substances has not been studied.

Limitations

Inaccuracy in glucose values obtained using the BG mode during calibration of the

System will affect the accuracy of the System.