Alinity m EBV (09N43-095)

Alinity m EBV is an in vitro PCR assay that quantifies Epstein-Barr Virus DNA in human EDTA plasma using the automated Alinity m System. It is intended to aid in the management of EBV in transplant patients by monitoring viral load to indicate the need for treatment changes and assess response to therapy. It is not intended for screening blood, blood products, or human cells and tissues for EBV.

The subject device is identical to the predicate device (K212778) except that it may use MomentaTaq HotStart DNA Polymerase as an alternative to KAPA2G HotStart DNA Polymerase in the reagent formulation. All other components, including oligonucleotide primers, probes, sample preparation, amplification technology, and assay controls remain unchanged.

The assay targets are traceable to the 1st World Health Organization International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques (NIBSC code 09/260). No other ISO, IEC, or ASTM standards are explicitly cited in this summary.

The device achieves substantial equivalence by demonstrating that the MomentaTaq polymerase formulation performs comparably to the KAPA2G formulation across multiple analytical performance metrics. The new formulation meets or exceeds the predicate's limit of detection (97.2% at 20 IU/mL), maintains linearity across the claimed range (15–250,000,000 IU/mL), achieves equivalent precision (SD ≤0.25 Log IU/mL for high concentrations, ≤0.50 for low), and shows clinically acceptable reproducibility at three sites. Method comparison with the predicate device yielded a correlation of 0.993 with minimal systematic bias (−0.01 Log IU/mL), demonstrating functional equivalence despite the enzyme substitution.