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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.
Classification Namekit, rna detection, human papillomavirus
PMA NumberP100042
Supplement NumberS004
Date Received12/24/2014
Decision Date06/05/2015
Product Code
OYB[ Registered Establishments with OYB ]
Advisory Committee Microbiology
Clinical Trials NCT00973362
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product 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 assay. The aptima hpv assay is an in vitro nucleic acid amplification test for the qualitative detection of e6/e7 viral messenger rna (mrna) from 14 high-risk types of human papillomavirus (hpv) in cervical specimens. The high-risk hpv types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The aptima hpv assay does not discriminate between the 14 high-risk types. 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 assay. The assay is used with the tigris dts system or the panther system. The use of the test is indicated: 1) to screen women 21 years and older with atypical squamous cells of undetermined significance (asc-us) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy; and 2) in women 30 years and older, the aptima hpv assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk hpv types. This information, together with the physician¿s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. * broom-type device (e. G. , wallach pipette) or endocervical brush/spatula.