Accuracy requirements for glucose meters
| Results | Current accuracy requirements | Future accuracy requirements |
|---|---|---|
| ≥ 75 mg/dL | 95% of meter results must be within ± 20% of the actual blood glucose level | 99% of meter results must be within ± 15% of the actual blood glucose level |
| < 75 mg/dL | 95% of meter results must be within ± 15 mg/dL of the actual blood glucose level | 99% of meter results must be within ± 15 mg/dL of the actual blood glucose level |
Information based on International Organization for Standardization (ISO). ISO 15197:2013. In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. www.iso.org/obp/ui/#iso:std:iso:15197:ed-2:v1:en. Accessed April 8, 2016.