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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.
 
DeviceOnclarity HPV Assay
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantBecton, Dickinson and Company
7loveton Cir.
Sparks, MD 21152
PMA NumberP160037
Supplement NumberS021
Date Received02/11/2025
Decision Date03/12/2025
Product Code MAQ 
Advisory Committee Microbiology
Clinical TrialsNCT06498661
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the SHIP-Sub-Protocol LMI-001-A-S01_Version 3.0 for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160037-S017.
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