{
  "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": "Eligible",
      "product_code": "NQL",
      "openfda": {
        "k_number": [
          "K173568",
          "K083130",
          "K193103",
          "DEN040002",
          "K093916"
        ],
        "registration_number": [
          "8043909"
        ],
        "fei_number": [
          "3002808498"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.",
      "regulation_number": "862.1055",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}