COBAS HPV TEST

Kit, Dna Detection, Human Papillomavirus

FDA Premarket Approval P100020 S008

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 cobas® hpv test. The cobas® hpv test indications for use: the cobas® hpv test is a qualitative in vitro test for the detection of human papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the thinprep® pap testtm preservcyt® solution. The test utilizes amplification of target dna by the polymerase chain reaction (pcr) and nucleic acid hybridization for the detection of 14 high-risk (hr) hpv types in a single analysis. The test specifically identifies types hpv16 and hpv18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas® hhpv test is indicated:1) to screen patients 21 years and older with asc-us (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy; 2) to be used in patients please see approval order for further information.

DeviceCOBAS HPV TEST
Classification NameKit, Dna Detection, Human Papillomavirus
Generic NameKit, Dna Detection, Human Papillomavirus
ApplicantRoche Molecular Systems, Inc.
Date Received2013-07-01
Decision Date2014-04-24
Notice Date2014-04-24
PMAP100020
SupplementS008
Product CodeMAQ
Docket Number14M-0552
Advisory CommitteeMicrobiology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P100020Original Filing
S054 2022-10-21 30-day Notice
S053 2020-07-27 30-day Notice
S052 2020-06-01 30-day Notice
S051 2020-04-17 30-day Notice
S050 2019-09-20 30-day Notice
S049
S048 2019-08-08 30-day Notice
S047 2019-04-24 30-day Notice
S046 2019-04-10 30-day Notice
S045 2019-04-08 30-day Notice
S044 2019-04-03 30-day Notice
S043 2019-02-04 30-day Notice
S042 2018-12-14 30-day Notice
S041 2018-11-13 30-day Notice
S040 2018-11-09 30-day Notice
S039 2018-10-25 30-day Notice
S038 2018-08-21 30-day Notice
S037 2018-07-27 30-day Notice
S036 2018-06-29 30-day Notice
S035 2018-06-08 30-day Notice
S034 2018-06-04 30-day Notice
S033 2018-05-23 30-day Notice
S032 2018-05-09 Real-time Process
S031 2018-05-04 30-day Notice
S030 2018-04-16 30-day Notice
S029 2018-03-01 30-day Notice
S028 2017-12-07 30-day Notice
S027 2017-10-30 30-day Notice
S026 2017-09-26 30-day Notice
S025 2017-07-28 Normal 180 Day Track
S024 2017-07-17 30-day Notice
S023 2017-07-14 30-day Notice
S022 2017-07-14 30-day Notice
S021 2016-09-22 30-day Notice
S020 2016-07-08 30-day Notice
S019 2016-04-18 30-day Notice
S018 2016-04-07 30-day Notice
S017 2015-12-23 Panel Track
S016
S015 2015-06-24 30-day Notice
S014 2015-03-13 30-day Notice
S013 2015-02-25 Real-time Process
S012 2013-11-05 Real-time Process
S011 2013-08-14 30-day Notice
S010 2013-08-09 30-day Notice
S009 2013-07-26 30-day Notice
S008 2013-07-01 Panel Track
S007 2012-10-09 30-day Notice
S006 2012-08-15 30-day Notice
S005 2012-07-02 Real-time Process
S004 2012-04-02 Normal 180 Day Track
S003 2012-03-29 Normal 180 Day Track No User Fee
S002 2011-12-12 135 Review Track For 30-day Notice
S001 2011-05-31 Normal 180 Day Track No User Fee

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