Alinity m CMV

The Alinity m CMV is an in vitro PCR assay that quantitates cytomegalovirus (CMV) DNA in human EDTA plasma using an automated Alinity m System. It is intended to aid in managing hematopoietic stem cell and solid organ transplant patients undergoing anti-CMV therapy and to assess virological response to treatment. The test is not intended for screening CMV in blood products.

The subject device is identical to the FDA-approved predicate (PMA P210022) except it may use an alternative DNA polymerase in place of the original polymerase for DNA amplification. All other reagent formulations, primers, probes, sample preparation, amplification technology, assay controls, and intended use remain unchanged.

The device quantitation is traceable to the 1st World Health Organization (WHO) International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC code 09/162). The document cites ISO, IEC, ASTM, or other formal consensus standards in the sections addressing analytical performance.

The alternative DNA polymerase formulation does not introduce new types of safety or effectiveness questions because all other aspects of the assay—sample processing, amplification/detection procedure, data reduction, workflow, and intended use—are identical to the predicate. Supplemental analytical studies (limit of detection, linearity, precision, lower limit of quantitation, reproducibility, and method comparison) demonstrate that the assay with the alternative polymerase meets or exceeds the same performance claims established for the original formulation, with clinically acceptable equivalence across the analytical measuring range.