{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QDJ",
      "openfda": {
        "k_number": [
          "K193492",
          "K221885",
          "DEN180028"
        ],
        "registration_number": [
          "3007699459"
        ],
        "fei_number": [
          "3007699459"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "MG",
      "device_name": "Direct-To-Consumer Access Pharmacogenetic Assessment System",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Medical Genetics",
      "device_class": "2",
      "definition": "A direct-to-consumer access pharmacogenetic assessment system is a qualitative in vitro molecular diagnostic system used for detecting variants in nucleic acids isolated from human specimens the purpose of identifying pharmacogenetic associations for the detected variants. This device is for in vitro diagnostic use only, and is intended for direct access testing by lay users.",
      "regulation_number": "862.3364",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}