The performance of the Applied Biosystems™ QuantStudio™5 Dx Real‑Time PCR System and the QuantStudio™ 7 Pro Dx Real‑Time PCR System to a respective predicate IVD PCR system is demonstrated. We report the results for reproducibility, repeatability, and method comparison studies using nucleic acid of influenza A and influenza B as the representative targets, detected with a clinically relevant assay to show substantial performance equivalence.