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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameAPTIMA HPV 16 18/45 GENOTYPE ASSAY
Classification Namekit, rna detection, human papillomavirus
ApplicantGEN-PROBE INCORPORATED
PMA NumberP120007
Supplement NumberS001
Date Received05/15/2013
Decision Date11/06/2013
Product Code
OYB[ Registered Establishments with OYB ]
Advisory Committee Microbiology
Clinical Trials NCT01694875
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the panther system to the aptima® hpv 16 18/45 genotype assay. 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.
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