Table 2.
System Accuracy Results for Each Individual Reagent System Lot (n = 200 per Lot).
| Within limits of | All glucose concentrations |
Glucose concentrations <100 mg/dl |
Glucose concentrations ≥100 mg/dl |
Consensus error grid |
Relative bias | Regression | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| ±15 mg/dl/15% | ±15 mg/dl | ±10 mg/dl | ±5 mg/dl | ±15% | ±10% | ±5% | Zones A+B | |||
| Lot 1 (I16D01A) | 99% | 100% | 92.9% | 69.9% | 98.6% | 93.8% | 70.8% | 100% | −0.6% | y = 1.05x–6.09 |
| Lot 2 (I16D02A) | 97% | 98.3% | 93.1% | 50% | 96.5% | 88.7% | 65.5% | −1.0% | y = 1.05x–7.58 | |
| Lot 3 (I16D03A) | 98.5% | 98.3% | 89.7% | 48.3% | 98.6% | 94.4% | 66.2% | −0.9% | y = 1.05x–7.70 | |