Premarket Approval (PMA)

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.

• Device: BD Onclarity HPV Assay
• Generic Name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
• Applicant: Becton, Dickinson and Company; 7loveton Cir.; Sparks, MD 21152
• PMA Number: P160037
• Supplement Number: S025
• Date Received: 10/08/2025
• Decision Date: 04/02/2026
• Product Code: MAQ
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to update labeling to reflect the findings of the Post-Approval Study P160037/S017/PAS001.