Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:

1. Successful in performing tasks correctly without assistance
2. Successful after study staff prompted participant to review User Guide.
3. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)
4. Subject did not perform task correctly and study staff intervention was required.

The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.

Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.

One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.

The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences

Some subjects >=13 yrs consented to provide larger capillary samples for YSI glucose analysis. One subject's sample was insufficient to run the YSI analysis. Another subject's results were not useable as the subject was given carbohydrate to prevent low blood sugar. Duplicate subject BG results provided 158 possible data points.

Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:

1. Successful in performing tasks correctly without assistance
2. Successful after study staff prompted participant to review User Guide.
3. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)
4. Subject did not perform task correctly and study staff intervention was required.

For 2 different subjects, study staff did not rate subject success at 1 task.

The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.

Meter results were used from subject and HCP data that had numeric values for duplicate BG self-tests. One subject data set was not used because subject was given carbohydrate to prevent low blood sugar. Two subjects' meter results contained outliers (NCCLS EP-9A) and one HCP's results had only one replicate result so these sets were not analyzed.