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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.
 
DeviceBD Onclarity HPV Assay
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantBECTON, DICKINSON AND COMPANY
7 LOVETON CIRCLE
SPARKS, MD 21152
PMA NumberP160037
Supplement NumberS017
Date Received08/28/2023
Decision Date05/14/2024
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The BD Onclarity HPV Assay is a qualitative in vitro test for the detection of high-risk (HR) Human Papillomavirus. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 HR HPV types in a single analysis. The test specifically identifies types 16, 18, 31, 45, 51, and 52 while reporting the other HR HPV types in groups (33/58, 35/39/68, and 56/59/66) in the specimens listed below. Clinician-collected cervical specimens should be obtained using an endocervical brush/spatula combination or broom and placed in a BD SurePath vial or placed in ThinPrep Pap Test PreservCyt Solution.Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical specimens otherwise cannot be obtained.The BD Onclarity HPV Assay is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of individuals with a cervix to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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