Arkray Glucocard Shine - Performance Characteristics and Accuracy Evaluation; System Accuracy Evaluation; Meter Precision Studies; Alternative Site Testing Evaluation

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Within Run Precision
*Bloodavg. 39 mg/dL SD = 1.9 mg/dL
*Bloodavg. 82 mg/dL SD = 2.7 mg/dL
*Bloodavg. 145 mg/dL CV = 2.9%
*Bloodavg. 179 mg/dL CV = 3.9%
*Bloodavg. 341 mg/dL CV = 2.5%
Total Precision
*Controlavg. 32 mg/dL SD = 1.7 mg/dL
*Controlavg. 121 mg/dL CV = 3.6%
*Controlavg. 354 mg/dL CV = 4.3%
Precision: Precision studies were performed in a laboratory
using the GLUCOCARD Shine System.
Alternative Sites Testing Evaluation
• Comparison of results using various AST sites with the results
of YSI measurements
Alternative site test results for glucose concentration < 75 mg/dL
This study shows that there could be variation of up to 4.3%.
Fingertip
Forearm
Palm
Thigh
Calf
Within ± 5 mg/dL
5/5 (100%)
5/5 (100%)
5/5 (100%)
4/5 (80%)
3/5 (60%)
Within ± 10 mg/dL
5/5 (100%)
5/5 (100%)
5/5 (100%)
5/5 (100%)
5/5 (100%)
Within ± 15 mg/dL
5/5 (100%)
5/5 (100%)
5/5 (100%)
5/5 (100%)
5/5 (100%)