Identity
- Trade Name
- BD ONCLARITY HPV ASSAY FDA PMA
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS FDA PMA
Identifiers
- PMA Number
- P160037 FDA PMA
- FDA Product Code
- MAQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The BD Onclarity HPV Assay is a qualitative in vitro test designed for the detection of Human Papillomavirus (HPV) in cervical specimens. It utilizes Polymerase Chain Reaction (PCR) amplification and nucleic acid hybridization to identify 14 high-risk HPV types in a single analysis, specifically distinguishing types 16, 18, and 45 while concurrently detecting others.
This assay is intended for use with cervical specimens collected by a clinician using an endocervical brush, spatula, or broom and placed in a BD SurePath vial. It is indicated for cervical cancer screening, adjunctive screening, and the management of patients with atypical squamous cells of undetermined significance (ASC-US) in accordance with professional guidelines. The device is authorized under FDA PMA and IVDR regulations.
Frequently asked questions
What types of HPV does the BD Onclarity HPV Assay detect?
The assay detects 14 high-risk HPV types in a single analysis. It specifically identifies genotypes 16, 18, and 45, while concurrently detecting 11 other high-risk types, including 31, 33, 35, 39, 51, 52, 56, 58, 59, 66, and 68.
How are the cervical specimens collected for this test?
Specimens must be collected by a clinician using an endocervical brush/spatula combination or a broom. Once collected, the samples must be placed in a BD SurePath vial for processing.
In what clinical scenarios is this assay indicated?
The assay is indicated for women 21 years and older with ASC-US cervical cytology results to determine the need for colposcopy, for adjunctive screening in women 30 years and older, and as a first-line primary cervical cancer screening test for women 25 years and older.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Becton Dickinson – Wikipedia, BD (company) - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | European Union | IVDR | — | Class III | Pending data |
| FDA PMA | United States | FDA_PMA | P160037 | Class III | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA PMA P160037 24 fields · synced Sep 18, 2026