BD Onclarity HPV Assay
FDA premarket approval P160037/S012 · decided 2023-02-15
Approval details
- PMA number
- P160037
- Supplement
- S012
- Supplement type
- Real-Time Process
- 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
- 2022-11-14
- Decision date
- 2023-02-15
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for The BD Onclarity HPV Assay. The device is indicated as a qualitative in vitro test for the detection of Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula combination or broom and placed in a BD SurePath vial or placed in ThinPrep Pap Test PreservCyt Solution . The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single
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