|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||APTIMA HPV 16 18/45 GENOTYPE ASSAY|
|Classification Name||kit, rna detection, human papillomavirus|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling for post approval study|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a post approval study labeling update. The device, as modified, will be marketed under the trade name aptima hpv 16 18/45 genotype assay. The aptima hpv 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of e6/e7 viral messenger rna (mrna) of human papillomavirus (hpv) types 16, 18, and 45 in cervical specimens from women with aptima hpv assay positive results. The aptima hpv 16 18/45 genotype assay can differentiate hpv 16 from hpv 18 and/or hpv 45, but does not differentiate between hpv 18 and hpv 45. Cervical specimens in thinprep pap test vials containing preservcyt solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the aptima hpv 16 18/45 genotype assay. The assay is used with the tigris dts system or the panther system. For further information please refer to the approval order.