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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 NumberS001
Date Received10/04/2012
Decision Date07/15/2013
Product Code
OYB[ Registered Establishments with OYB ]
Advisory Committee Microbiology
Clinical Trials NCT01446198
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the panther system to the aptima® hpv assay. 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 collected in thinprep pap test vials containing presesrvcyt 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 physicians 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.