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Precision
Precision studies were performed in a laboratory using the
GLUCOCARD Shine Express Blood Glucose Monitoring System.
User performance results for glucose concentrations between
48 mg/dL and 553 mg/dL.
Within ± 15 mg/dL and Within ± 20%
371/371 (100%)
Within Run Precision
Blood avg.
43 mg/dL
SD = 1.9 mg/dL CV = 4.3%
Blood avg.
71 mg/dL
SD = 2.1 mg/dL CV = 2.9%
Blood avg.
135 mg/dL
SD = 3.8 mg/dL CV = 2.8%
Blood avg.
203 mg/dL
SD = 5.2 mg/dL CV = 2.6%
Blood avg.
343 mg/dL
SD = 11 mg/dL
CV = 3.2%
Between Run Precision
Control avg.
36 mg/dL
SD = 1.4 mg/dL CV = 3.8%
Control avg.
114 mg/dL
SD = 3.4 mg/dL CV = 3.0%
Control avg.
341 mg/dL
SD = 8.2 mg/dL CV = 2.4%
Summary of Contents for Gluocard Shine Express
Page 1: ...User Manual For single user home use only ...
Page 4: ......