|Trade Name||COBAS AMPLIPREP/COBAS TAQMAN CMV TEST|
|Classification Name||cytomegalovirus (cmv) dna quantitative assay|
|Applicant||ROCHE MOLECULAR SYSTEMS, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the test definition file (tdf). The device, as modified, will be marketed under the trade name cobas ampliprep/cobas taqman cmv test and is indicated for: cobas ampliprep/cobas taqman cmv test the cobas ampliprep/ cobas taqman cmv test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (cmv) dna in human edta plasma using the cobas ampliprcp instrument for automated specimen processing and the cobas taqman analyzer or the cobas taqman 48 analyzer for automated amplification and detection. The cobas ampliprcp/ cobas taqman cmv test is intended for usc as an aid in the management ofsolid-organ transplant patients who arc undergoing anti-cmv therapy. In this population serial dna measurements can be used to assess virological response to antiviral treatment. The results from the cobas ampliprep/cobas taqman cmv test must be interpreted within the context of all relevant clinical and laboratory findings. The cobas ampliprep/ cobas taqman cmv test is not intended for use as a screening test for the presence of cmv dna in blood or blood products.