Results of the rFC Robustness Study
| Parameter | Method Acceptance Criteria | Minimum Result From Study | Maximum Result From Study |
|---|---|---|---|
| Correlation coefficient | Within 0.980–1.000 | 0.999 | 1.000 |
| Slope | Between 0.500 and 1.500 | 0.931 | 0.951 |
| Y-intercept | Between 2.500 and 5.000 | 3.394 | 3.923 |
| %CV of test replicates | NMT 25% | n/a | 5% |
| 0.5 EU/mL solution | 50–200% | 110% | 125% |