Performance Characteristics; Glucose: Accuracy - A.MENARINI GlucoMen Day METER 2K User Manual

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Performance Characteristics

The performance of GlucoMen
Monitoring in glucose measurement has been evaluated in laboratory
and in clinical tests following ISO 15197:2013 (EN ISO 15197:2015).
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Glucose: Accuracy

The accuracy of the GlucoMen
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 diabetic patients
at clinic centres.
System accuracy results for glucose concentration
< 100 mg/dL
Within ± 5 mg/dL
133/168 (79.2 %)
System accuracy results for glucose concentration
≥ 100 mg/dL
Within ± 5 %
290/432 (67.1 %)
Day METER 2K Blood Glucose / β-Ketone
®
Day METER 2K system was assessed
®
Within ± 10 mg/dL
162/168 (96.4 %)
Within ± 10 %
424/432 (98.1 %)
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Within ± 15 mg/dL
168/168 (100 %)
Within ± 15 %
432/432 (100 %)
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