Table 1.
Summary of BGMS Results From the Laboratory Study (ISO 15197:2013 Section 6.3).
| Blood glucose concentration | Test strip lot | N | Number (%) of results within specified error limits | ||
|---|---|---|---|---|---|
| <100 mg/dl (<5.6 mmol/L) | ±5 mg/dl (±0.3 mmol/L) | ±10 mg/dl (±0.6 mmol/L) | ±15 mg/dl (±0.8 mmol/L)a | ||
| Lot 1 | 70 | 64 (91.4) | 70 (100.0) | 70 (100.0) | |
| Lot 2 | 70 | 62 (88.6) | 70 (100.0) | 70 (100.0) | |
| Lot 3 | 70 | 65 (92.9) | 70 (100.0) | 70 (100.0) | |
| Combined | 210 | 191 (91.0) | 210 (100.0) | 210 (100.0) | |
| ≥100 mg/dl (≥5.6 mmol/L) | ±5% | ±10% | ±15%a | ||
| Lot 1 | 130 | 96 (73.8) | 129 (99.2) | 130 (100.0) | |
| Lot 2 | 130 | 74 (56.9) | 124 (95.4) | 130 (100.0) | |
| Lot 3 | 130 | 87 (66.9) | 127 (97.7) | 130 (100.0) | |
| Combined | 390 | 257 (65.9) | 380 (97.4) | 390 (100.0) | |
| Total | ±5 mg/dl (±0.3 mmol/L) or ±5% | ±10 mg/dl (±0.6 mmol/L) or ±10% | ±15 mg/dl (±0.8 mmol/L)a or ±15%a | ||
| Lot 1 | 200 | 160 (80.0) | 199 (99.5) | 200 (100.0) | |
| Lot 2 | 200 | 136 (68.0) | 194 (97.0) | 200 (100.0) | |
| Lot 3 | 200 | 152 (76.0) | 197 (98.5) | 200 (100.0) | |
| Combined | 600 | 448 (74.7) | 590 (98.3) | 600 (100.0) | |
BGMS, blood glucose monitoring system; ISO, International Organization for Standardization.
a
ISO 15197:2013 Section 6.3 accuracy criteria.