{
  "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": "OIU",
      "openfda": {
        "k_number": [
          "K112624",
          "K093957",
          "K072939",
          "K151378",
          "K103676"
        ],
        "registration_number": [
          "2521625",
          "9610126",
          "3005333358",
          "3002809144",
          "2032839"
        ],
        "fei_number": [
          "3004185580",
          "3002806559",
          "2521625",
          "3005333358",
          "3002809144"
        ]
      },
      "review_panel": "IM",
      "medical_specialty": "IM",
      "device_name": "Test, Epithelial Ovarian Tumor Associated Antigen (He4)",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "An enzyme immunometric assay for the quantitative determination of HE4 in human serum.   The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.",
      "regulation_number": "866.6010",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}