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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceAPTIMA HPV ASSAY
Classification Namekit, rna detection, human papillomavirus
Generic Namekit, rna detection, human papillomavirus
Applicant
GEN-PROBE INCORPORATED
10210 genetic center drive
san diego, CA 92121
PMA NumberP100042
Date Received11/05/2010
Decision Date10/28/2011
Product Code
OYB[ Registered Establishments with OYB ]
Docket Number 11M-0792
Notice Date 11/04/2011
Advisory Committee Microbiology
Clinical Trials NCT00973362
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the aptima hpv assay. Aptima hpv assay indications for use:the aptima hpv assay is an in vitro nucleic acid amplification test for the qualitative detectionofe6/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 the14 high-risk types. Cervical specimens in thinprep pap test vials containing preservcyt solutionand collected with broom-type or cytobrush/ spatula collection devices* may be tested with theaptima hpv assay. The assay is used with the tigris dts system. The use of the test is indicated:i. To screen patients 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 tocolposcopy. 2. In women 30 years and older, the aptima hpv assay can be used with cervical cytologyto 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S009 S010 
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