{
  "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": "2026-09-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 8
    }
  },
  "results": [
    {
      "pma_number": "P240010",
      "supplement_number": "",
      "applicant": "Caris Life Sciences",
      "street_1": "4610 S. 44th Pl.",
      "street_2": "",
      "city": "Phoenix",
      "state": "AZ",
      "zip": "85040",
      "zip_ext": "",
      "generic_name": "Next generation sequencing oncology panel, somatic or germline variant detection system",
      "trade_name": "MI Cancer Seek",
      "product_code": "PQP",
      "advisory_committee": "MG",
      "advisory_committee_description": "Medical Genetics",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2024-04-01",
      "decision_date": "2024-11-05",
      "docket_number": "24M-5719",
      "fed_reg_notice_date": "2024-12-20",
      "decision_code": "APPR",
      "ao_statement": "Approval order for MI Cancer Seek. MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI), tumor mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in Table 1 below, in accordance with the approved therapeutic product labeling (see approval order for Table 1).Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed in Table 1 are not prescriptive or conclusive for labeled use of any specific therapeutic product.",
      "openfda": {
        "registration_number": [
          "3017020141",
          "3013200421",
          "3003335080",
          "3010679023",
          "3010889807",
          "3031598391",
          "3012090384",
          "3030654068",
          "3011104381",
          "3003218906",
          "3020703032",
          "3007287152"
        ],
        "fei_number": [
          "3013200421",
          "3003335080",
          "3010679023",
          "3010889807",
          "3016560486",
          "3031598391",
          "3012090384",
          "3030654068",
          "3008335090",
          "3011104381",
          "3003218906",
          "3007287152"
        ],
        "device_name": "Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}