|Trade Name||ARTUS CMV RGQ MDX KIT|
|Classification Name||cytomegalovirus (cmv) dna quantitative assay|
|Docket Number|| 14M-0866|
|Notice Date|| 06/30/2014|
|Expedited Review Granted?|| No|
||Labeling, Approval Order, Summary of Safety and Effectiveness|
|Approval Order Statement |
Approval for the artus cmv rgq mdx kit. This device is indicated for: the artus cmv rgq mdx kit is an in vitro nucleic acid amplification test for the quantitation of human cytomegalovirus (cmv) dna in human edta plasma. The artus cmv rgq mdx kit is intended for use as an aid in the management of solid organ transplant patients who are undergoing anti-cmv therapy. The test measures cmv dna levels in edta plasma and can be used to assess cmv viral load response to antiviral drug therapy. The results from the artus cmv rgq mdx kit must be interpreted within the context of all relevant clinical and laboratory findings. The artus cmv rgq mdx kit is configured for use with the ez1 dsp virus system (ez1 dsp virus kit and ez1 advanced instruments) for dna extraction and the rotor-gene q mdx instrument for cmv dna amplification and quantitation. The artus cmv rgq mdx kit is not intended for use as a screening test for blood or blood products.