{
  "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": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PTF",
      "openfda": {
        "k_number": [
          "K242294",
          "K162297",
          "K192271",
          "K222996"
        ],
        "registration_number": [
          "3006644620",
          "3008344661",
          "2122870",
          "2032900",
          "3005333358",
          "3002809144",
          "1616487",
          "1181121"
        ],
        "fei_number": [
          "3006644620",
          "3008344661",
          "2122870",
          "3004445302",
          "3005333358",
          "3002809144",
          "1616487",
          "1181121"
        ]
      },
      "review_panel": "MI",
      "medical_specialty": "MI",
      "device_name": "Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Microbiology",
      "device_class": "2",
      "definition": "Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock",
      "regulation_number": "866.3215",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}