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1. Method Comparison
The accuracy of the SD GlucoNavii™ blood glucose monitoring system was assessed
by comparing blood glucose results obtained by patients with those obtained using a
YSI Model 2300 STAT Plus glucose analyzer(reference), a laboratory instrument.
2. User Performance Evaluation
System Accuracy (from layman)
Diabetes experts have suggested that glucose meters should agree within 15 mg/dL
of a laboratory method when the glucose concentration is lower than 75 mg/ dL, and
within 20% of a laboratory method when the glucose concentration is 75 mg/dL or high-
er. The chart below displays how often the SD GlucoNavii™ meter achieves this goal.
The chart is based on a study done to see how well the SD GlucoNavii™ compared to
laboratory results.
Содержание SD Gluco Navii
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Страница 37: ...35 Attachment 3 QUALITY CONTROL RESULT RECORD SD GlucoNavii Blood Glucose Monitoring System...
Страница 38: ...36 Attachment 3 QUALITY CONTROL RESULT RECORD SD GlucoNavii Blood Glucose Monitoring System...
Страница 40: ...GlucoNavii Distributed by MAXPERT Medical Expert Products for Expert Care...