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The performance of AutoChek t Blood Glucose Monitoring System Strips has been
evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the AutoChek t BGM System (ModelGM505YAA) was
assessed by comparing blood glucose results obtained by patients with those
obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument
The following results were obtained by 110 diabetic patients at clinic centers.
Accuracy results for glucose concentration<75 mg/dL (4.2 mmol/L)
Accuracy results for glucose concentration
≧
75 mg/dL (4.2 mmol/L)
Slope
Y-intercept
Correlation coefficient(r)
Number of sample
Range tested
0.961
3.5 mg/dL
0.995
110
30 ~ 485 mg/dL
Within±5mg/dL
(Within±0.28mmol/dL)
Within±10mg/dL
(Within±0.56mmol/dL)
Within±15mg/dL
(Within±0.83mmol/dL)
13/17(76%) 16/17(94%)
17/17(100%)
Within±5% Within
±10%
Within±15% Within±20%
45/93(48%) 88/93(96%) 93/93(100%) 93/93(100%)
Performance Characteristic
