Aptima HPV Assay

FDA Premarket Approval P100042 S028

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

To add an alternate cleaning method for the sample shields and target capture reagent (tcr) adapters used on the panther/panther fusion instruments

DeviceAptima HPV Assay
Generic NameKit, Rna Detection, Human Papillomavirus
ApplicantGEN-PROBE INCORPORATED
Date Received2019-12-23
Decision Date2020-01-21
PMAP100042
SupplementS028
Product CodeOYB 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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
15420045500068 P100042 001
15420045500075 P100042 001
15420045500082 P100042 001
15420045500099 P100042 001
15420045500105 P100042 001
15420045500051 P100042 001
15420045500068 P100042 001
15420045500075 P100042 001
15420045500082 P100042 001
15420045500099 P100042 001
15420045500051 P100042 001

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