BD ONCLARITY HPV ASSAY
FDA premarket approval P160037 · decided 2018-02-12
Approval details
- PMA number
- P160037
- Trade name
- BD ONCLARITY HPV ASSAY
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2016-08-24
- Decision date
- 2018-02-12
- Days to decision
- 537 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 BD Onclarity HPV Assay is a qualitative in vitro test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula combination or broom and placed in BD SurePath vial. The test utilizes amplification of target DNA by Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types 1
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