{
  "code": "JIT",
  "deviceName": "Calibrator, Secondary",
  "deviceClass": "II",
  "regulationNumber": "862.1150",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 245,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 26,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 41,
    "sampleSize": 245
  },
  "recalls": {
    "total": 55,
    "recent": [
      {
        "resNumber": "Z-2894-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Aniara Diagnostica LLC",
        "firmAsPublished": "Aniara Diagnostica LLC",
        "reason": "Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.",
        "initiated": "2026-07-01"
      },
      {
        "resNumber": "Z-1848-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.",
        "initiated": "2025-04-24"
      },
      {
        "resNumber": "Z-1849-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.",
        "initiated": "2025-04-24"
      },
      {
        "resNumber": "Z-1850-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.",
        "initiated": "2025-04-24"
      },
      {
        "resNumber": "Z-1851-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.",
        "initiated": "2025-04-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K171168",
      "deviceName": "VITROS Immunodiagnostic Products Insulin Calibrators",
      "applicant": "Ortho Clinical Diagnostics",
      "company": "Ortho-Clinical Diagnostics, Inc.",
      "decisionDate": "2017-05-16",
      "dateReceived": "2017-04-21"
    },
    {
      "kNumber": "K170938",
      "deviceName": "CalSet IGF-1",
      "applicant": "Roche Diagnostics",
      "company": "Roche Diagnostics Corporation",
      "decisionDate": "2017-04-26",
      "dateReceived": "2017-03-30"
    },
    {
      "kNumber": "K170160",
      "deviceName": "Abbott ARCHITECT Free T3",
      "applicant": "Abbott Laboratories",
      "company": "Abbott Laboratories, Inc.",
      "decisionDate": "2017-02-15",
      "dateReceived": "2017-01-18"
    },
    {
      "kNumber": "K163546",
      "deviceName": "Lumipulse G Progesterone-N Calibrators",
      "applicant": "Fujirebio Diagnostics,Inc.",
      "company": "Fujirebio Diagnostics, Inc.",
      "decisionDate": "2017-01-13",
      "dateReceived": "2016-12-16"
    },
    {
      "kNumber": "K163534",
      "deviceName": "Lumipulse G FSH-N Calibrators",
      "applicant": "Fujirebio Diagnostics,Inc.",
      "company": "Fujirebio Diagnostics, Inc.",
      "decisionDate": "2017-01-13",
      "dateReceived": "2016-12-16"
    },
    {
      "kNumber": "K163544",
      "deviceName": "Lumipulse G Prolactin",
      "applicant": "Fujirebio Diagnostics,Inc.",
      "company": "Fujirebio Diagnostics, Inc.",
      "decisionDate": "2017-01-12",
      "dateReceived": "2016-12-16"
    },
    {
      "kNumber": "K163521",
      "deviceName": "Lumipulse G LH Calibrators",
      "applicant": "Fujirebio Diagnostics,Inc.",
      "company": "Fujirebio Diagnostics, Inc.",
      "decisionDate": "2017-01-12",
      "dateReceived": "2016-12-15"
    },
    {
      "kNumber": "K163078",
      "deviceName": "DC-UIBC-CAL",
      "applicant": "Sekisui Diagnostics P.E.I., Inc.",
      "company": "Sekisui Diagnostics P.E.I. Inc.",
      "decisionDate": "2016-12-08",
      "dateReceived": "2016-11-03"
    },
    {
      "kNumber": "K163053",
      "deviceName": "Lumipulse G E2-III Calibrators",
      "applicant": "Fujirebio Diagnostics,Inc.",
      "company": "Fujirebio Diagnostics, Inc.",
      "decisionDate": "2016-12-01",
      "dateReceived": "2016-11-01"
    },
    {
      "kNumber": "K162538",
      "deviceName": "ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator",
      "applicant": "Siemens Healthcare Diagnostics",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2016-11-17",
      "dateReceived": "2016-09-12"
    }
  ],
  "topApplicants": [
    {
      "name": "Dade Behring, Inc.",
      "count": 29
    },
    {
      "name": "Wako Chemicals USA, Inc.",
      "count": 15
    },
    {
      "name": "E.I. Dupont DE Nemours & Co., Inc.",
      "count": 10
    },
    {
      "name": "Roche Diagnostics Corp.",
      "count": 10
    },
    {
      "name": "Diamond Diagnostics, Inc.",
      "count": 9
    }
  ],
  "topCompanies": [
    {
      "name": "Dade Behring, Inc.",
      "count": 29,
      "spellings": 1
    },
    {
      "name": "Roche Diagnostics Corporation",
      "count": 18,
      "spellings": 2
    },
    {
      "name": "Wako Chemicals USA, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Siemens Healthcare Diagnostics, Inc.",
      "count": 11,
      "spellings": 2
    },
    {
      "name": "E.I. Dupont DE Nemours & Co., Inc.",
      "count": 10,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JIT (Calibrator, Secondary) has one finding. 1 recall opened in the last 12 months and not yet terminated (Z-2894-2026).",
    "severity": 70,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated",
        "recordIds": [
          "Z-2894-2026"
        ],
        "severity": 70
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AJIT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJIT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJIT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJIT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJIT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJIT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJIT"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.719Z"
}