Table 1.
Minimum SMBG System Accuracy Criteria According to the ISO 15197 Standard in Its 2003 and 2013 Versions and the FDA Draft Guidance Document From 2014.
| ISO 15197:2003 | ISO 15197:2013 | FDAa | ||||
|---|---|---|---|---|---|---|
| Relative number of results | 95% | 95%b | 95% | 99% | ||
| Within | ±15 mg/dl | ±20% | ±15 mg/dl | ±15% | ±15% | ±20% |
| At BG concentrations | <75 mg/dl | ≥75 mg/dl | <100 mg/dl | ≥100 mg/dl | Entire range | |
| 99% of results within CEG zones A + B | ||||||
a
FDA draft guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, published in 2014.
b
In ISO 15197:2013 this acceptance criterion is also applied for the user performance evaluation.