Comparison of ISO 15197:2013 and FDA blood glucose meter accuracy standards
| Setting . | FDA (224,225) . | ISO 15197:2013 (226) . |
|---|---|---|
| Home use | 95% within 15% for all BG in the usable BG range† 99% within 20% for all BG in the usable BG range† | 95% within 15% for BG ≥100 mg/dL 95% within 15 mg/dL for BG <100 mg/dL 99% in A or B region of consensus error grid‡ |
| Hospital use | 95% within 12% for BG ≥75 mg/dL 95% within 12 mg/dL for BG <75 mg/dL 98% within 15% for BG ≥75 mg/dL 98% within 15 mg/dL for BG <75 mg/dL |
| Setting . | FDA (224,225) . | ISO 15197:2013 (226) . |
|---|---|---|
| Home use | 95% within 15% for all BG in the usable BG range† 99% within 20% for all BG in the usable BG range† | 95% within 15% for BG ≥100 mg/dL 95% within 15 mg/dL for BG <100 mg/dL 99% in A or B region of consensus error grid‡ |
| Hospital use | 95% within 12% for BG ≥75 mg/dL 95% within 12 mg/dL for BG <75 mg/dL 98% within 15% for BG ≥75 mg/dL 98% within 15 mg/dL for BG <75 mg/dL |
BG, blood glucose; FDA, U.S. Food and Drug Administration; ISO, International Organization for Standardization. To convert mg/dL to mmol/L, see endmemo.com/medical/unitconvert/Glucose.php.
The range of blood glucose values for which the meter has been proven accurate and will provide readings (other than low, high, or error).
Values outside of the “clinically acceptable” A and B regions are considered “outlier” readings and may be dangerous to use for therapeutic decisions (228).