{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NYI",
      "openfda": {
        "k_number": [
          "K081092",
          "K141771",
          "K070675",
          "K101454",
          "K130010",
          "DEN070009",
          "K080252",
          "K141142",
          "K210973",
          "K201902"
        ],
        "registration_number": [
          "3007297853",
          "3017845262",
          "3039487170",
          "2032839"
        ],
        "fei_number": [
          "3007297853",
          "3017845262",
          "3039487170",
          "3004185580"
        ]
      },
      "review_panel": "PA",
      "medical_specialty": "IM",
      "device_name": "Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Immunology",
      "device_class": "2",
      "definition": "A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer.  The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.",
      "regulation_number": "866.6040",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}