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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBD ONCLARITY HPV ASSAY
Classification Namekit, dna detection, human papillomavirus
Generic Namekit, dna detection, human papillomavirus
Applicant
BECTON, DICKINSON AND COMPANY
7 loveton circle
sparks, MD 21152
PMA NumberP160037
Date Received08/24/2016
Decision Date02/12/2018
Product Code
MAQ[ Registered Establishments with MAQ ]
Docket Number 18M-0736
Notice Date 03/01/2018
Advisory Committee Microbiology
Clinical Trials NCT01944722
NCT02267876
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the BD Onclarity HPV Assay. The BD Onclarity HPV Assay is a qualitative in vitro test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula combination or broom and placed in BD SurePath vial. The test utilizes amplification of target DNA by 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 16, 18 and 45 while concurrently detecting the other HR HPV types that include 31, 33, 35, 39, 51, 52, 56, 58, 59, 66 and 68. The BD Onclarity HPV Assay is indicated: 1) In women 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results, the BD Onclarity HPV Assay can be used to determine the need for referral to colposcopy;2) In women 21 years and older with ASC-US cervical cytology test results, the BD Onclarity HPV assay can be used to detect high-risk HPV genotypes 16, 18 and 45. This information together with 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 BD Onclarity HPV Assay can be used together with cervical cytology to adjunctively screen to detect high risk HPV types. This information, together with the physicians assessment of screening history, other factors, and professional guidelines, may be used to guide patient management;4) In women 30 years and older, the BD Onclarity HPV Assay can be used to detect high-risk HPV genotypes 16, 18 and 45. This information, together with the physicians assessment of screening history, other factors, and professional guidelines, may be used to guide patient management; and5) In women 25 years and older, the BD Onclarity HPV Assay can be used as a first-line primary cervical cancer screening test to detect high risk HPV, including 16 and 18. Women who test negative for the high risk HPV types by the BD Onclarity HPV Assay 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 BD Onclarity HPV Assay should be referred to colposcopy. Women who test high risk HPV positive and 16 and 18 negative by the BD Onclarity HPV Assay (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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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