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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceCOBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS
Classification Namekit, dna detection, human papillomavirus
Generic Namekit, dna detection, human papillomavirus
Applicant
Roche Molecular Systems, Inc.
4300 hacienda drive
pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS017
Date Received12/23/2015
Decision Date07/07/2016
Product Code
MAQ[ Registered Establishments with MAQ ]
Docket Number 16M-1917
Notice Date 07/19/2016
Advisory Committee Microbiology
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the cobas® HPV Test. 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 or using a cervical broom and placed in SurePath Preservative Fluid. 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® HPV 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 21 years and older with ASC-US cervical cytology results, to detect high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy; 3) In women 30 years and older, the cobas® HPV Test can be used with cervical cytology to adjunctively screen to detect high risk HPV types. This information, together with the physician’s assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management; 4) In women 30 years and older, the cobas® HPV Test can be used to detect HPV genotypes 16 and 18. This information, together with the physicians assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management; and 5) In women 25 years and older, the cobas® HPV Test can be used for specimens collected only in ThinPrep® Pap TestTM PreservCyt® Solution as a first-line primary cervical cancer screening test to detect high risk HPV, including genotyping for 16 and 18. Women who test negative for high risk HPV types by the cobas® HPV Test should be followed up in accordance with the physicians assessment of screening and medical history, other risk factors, and professional guidelines. Women who test positive for HPV genotypes 16 and/or 18 by the cobas® HPV Test should be referred to colposcopy. Women who test high risk HPV positive and 16/18 negative by the cobas® HPV Test (12 other HR HPV positive) should be evaluated by cervical cytology to determine the need for referral to colposcopy.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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