{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "pma_number": "P160037",
      "supplement_number": "S017",
      "applicant": "Becton, Dickinson and Company",
      "street_1": "7loveton Cir.",
      "street_2": "",
      "city": "Sparks",
      "state": "MD",
      "zip": "21152",
      "zip_ext": "",
      "generic_name": "KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS",
      "trade_name": "BD Onclarity HPV Assay",
      "product_code": "MAQ",
      "advisory_committee": "MI",
      "advisory_committee_description": "Microbiology",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2023-08-28",
      "decision_date": "2024-05-14",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_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 specimens should be obtained using an endocervical brush/spatula combination or broom and placed in a BD SurePath vial or placed in ThinPrep Pap Test PreservCyt Solution.Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical specimens otherwise cannot be obtained.The BD Onclarity HPV Assay is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of individuals with a cervix to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.",
      "openfda": {
        "registration_number": [
          "2243471",
          "3004141078",
          "2028492",
          "9610126",
          "1119779",
          "3003795116",
          "3019837962",
          "1122376",
          "2134567",
          "3005406097",
          "3005248192"
        ],
        "fei_number": [
          "3003572099",
          "2243471",
          "3004141078",
          "1119779",
          "3003795116",
          "3019837962",
          "3002622561",
          "3005406097",
          "1000125183",
          "3002806559",
          "3005248192"
        ],
        "device_name": "Kit, Dna Detection, Human Papillomavirus",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}