BD Onclarity HPV Assay
FDA premarket approval P160037/S004 · decided 2020-06-12
Approval details
- PMA number
- P160037
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BD Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2019-11-07
- Decision date
- 2020-06-12
- Days to decision
- 218 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for changes to labeling to include expansion of the assay reporting claims to include additional high-risk HPV genotypes (beyond HPV 16, 18 and 45). The BD Onclarity HPV Assay is 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. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridi
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