BD Onclarity HPV Assay
FDA premarket approval P160037/S024 · decided 2026-04-02
Approval details
- PMA number
- P160037
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2025-07-31
- Decision date
- 2026-04-02
- Days to decision
- 245 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for expanding settings under which self-collected vaginal (SV) specimens are collected and for adding a workflow for SV specimen processing and testing.
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