APTIMA HPV ASSAY

Kit, Rna Detection, Human Papillomavirus

FDA Premarket Approval P100042 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a change to the aptima hpv assay software from version 4. 2. 0 to version 4. 2. 1. This change is being implemented to reduce the probe reagent mixing speed in the hybridization protection assay (hpa) incubator from 14 hz to 5 hz on the tigris system. 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.

DeviceAPTIMA HPV ASSAY
Classification NameKit, Rna Detection, Human Papillomavirus
Generic NameKit, Rna Detection, Human Papillomavirus
ApplicantGEN-PROBE INCORPORATED
Date Received2015-08-12
Decision Date2015-11-24
PMAP100042
SupplementS007
Product CodeOYB
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121

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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