Table 7.1.

Comparison of ISO 15197:2013 and FDA blood glucose meter accuracy standards

Setting	FDA (248,254)	ISO 15197:2013 (255)
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 (256).