BD Onclarity HPV Assay
FDA premarket approval P160037/S025 · decided 2026-04-02
Approval details
- PMA number
- P160037
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- BD Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2025-10-08
- Decision date
- 2026-04-02
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval to update labeling to reflect the findings of the Post-Approval Study P160037/S017/PAS001.
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