BD Onclarity HPV Assay
FDA premarket approval P160037/S017 · decided 2024-05-14
Approval details
- PMA number
- P160037
- Supplement
- S017
- Supplement type
- Panel 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
- 2023-08-28
- Decision date
- 2024-05-14
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- The BD Onclarity HPV Assay is a qualitative in vitro test for the detection of high-risk (HR) Human Papillomavirus. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 HR HPV types in a single analysis. The test specifically identifies types 16, 18, 31, 45, 51, and 52 while reporting the other HR HPV types in groups (33/58, 35/39/68, and 56/59/66) in the specimens listed below. Clinician-collected cervical sp
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