Onclarity HPV Assay
FDA premarket approval P160037/S021 · decided 2025-03-12
Approval details
- PMA number
- P160037
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2025-02-11
- Decision date
- 2025-03-12
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- 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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