APTIMA HPV ASSAY

Kit, Rna Detection, Human Papillomavirus

FDA Premarket Approval P100042

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

DeviceAPTIMA HPV ASSAY
Classification NameKit, Rna Detection, Human Papillomavirus
Generic NameKit, Rna Detection, Human Papillomavirus
ApplicantGEN-PROBE INCORPORATED
Date Received2010-11-05
Decision Date2011-10-28
Notice Date2011-11-04
PMAP100042
SupplementS
Product CodeOYB
Docket Number11M-0792
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100042Original Filing
S033 2022-01-19 30-day Notice
S032
S031 2020-07-09 30-day Notice
S030 2020-05-14 30-day Notice
S029 2020-02-03 30-day Notice
S028 2019-12-23 Real-time Process
S027
S026 2019-08-21 30-day Notice
S025 2019-08-02 30-day Notice
S024
S023 2019-03-27 30-day Notice
S022 2019-03-18 Real-time Process
S021 2019-02-21 30-day Notice
S020 2018-12-31 Real-time Process
S019 2018-08-31 30-day Notice
S018 2018-08-16 30-day Notice
S017 2018-03-15 30-day Notice
S016 2018-02-08 30-day Notice
S015 2017-12-20 30-day Notice
S014 2017-10-10 30-day Notice
S013 2017-09-01 Normal 180 Day Track
S012 2017-03-17 Real-time Process
S011 2016-08-15 30-day Notice
S010 2016-04-25 30-day Notice
S009 2015-10-16 30-day Notice
S008 2015-08-28 135 Review Track For 30-day Notice
S007 2015-08-12 Normal 180 Day Track
S006
S005 2015-03-04 30-day Notice
S004 2014-12-24 Normal 180 Day Track No User Fee
S003 2014-06-09 30-day Notice
S002 2014-04-17 Real-time Process
S001 2012-10-04 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045500105 P100042 001
15420045500099 P100042 001
15420045500082 P100042 001
15420045500075 P100042 001
15420045500068 P100042 001
15420045500051 P100042 001

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