Aptima HPV 16 18/45 Genotype Assay

Kit, Rna Detection, Human Papillomavirus

FDA Premarket Approval P120007 S011

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 the use of the aptima hpv 16 18/45 genotype assay on panther systems equipped with a panther fusion module. The changes required for addition of the panther fusion module that are subject to this approval include reconfiguration of the panther system hardware, and updates to the panther system and aptima hpv 16 18/45 genotype assay software.

DeviceAptima HPV 16 18/45 Genotype Assay
Classification NameKit, Rna Detection, Human Papillomavirus
Generic NameKit, Rna Detection, Human Papillomavirus
ApplicantGEN-PROBE INCORPORATED
Date Received2017-09-01
Decision Date2018-02-23
PMAP120007
SupplementS011
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
P120007Original Filing
S029 2021-12-14 Real-time Process
S028 2020-07-09 30-day Notice
S027 2020-05-14 30-day Notice
S026 2019-12-23 Real-time Process
S025
S024 2019-08-21 30-day Notice
S023 2019-08-02 30-day Notice
S022
S021 2019-03-27 30-day Notice
S020 2019-03-18 Real-time Process
S019 2019-03-01 Real-time Process
S018 2018-12-31 Real-time Process
S017 2018-08-31 30-day Notice
S016 2018-08-16 30-day Notice
S015 2018-03-15 30-day Notice
S014 2018-02-08 30-day Notice
S013 2017-12-20 30-day Notice
S012 2017-10-10 30-day Notice
S011 2017-09-01 Normal 180 Day Track
S010 2017-03-17 Real-time Process
S009 2016-08-15 30-day Notice
S008 2016-03-01 30-day Notice
S007 2015-10-16 30-day Notice
S006 2015-08-28 135 Review Track For 30-day Notice
S005
S004 2015-03-04 30-day Notice
S003 2014-12-24 Normal 180 Day Track No User Fee
S002 2014-04-17 Real-time Process
S001 2013-05-15 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045500136 P120007 001
15420045500129 P120007 001
15420045500112 P120007 001

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