{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "ONX",
      "openfda": {
        "k_number": [
          "K151502",
          "K160090",
          "K103358",
          "K150588",
          "DEN090004",
          "K153607"
        ],
        "registration_number": [
          "2521625",
          "3005333358",
          "3002809144",
          "3004869564",
          "1415939"
        ],
        "fei_number": [
          "2521625",
          "3005333358",
          "3002809144",
          "3004869564",
          "1415939"
        ]
      },
      "review_panel": "IM",
      "medical_specialty": "OB",
      "device_name": "Ovarian Adnexal Mass Assessment Score Test System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Obstetrics/Gynecology",
      "device_class": "2",
      "definition": "An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum.  It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant.  The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.",
      "regulation_number": "866.6050",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}