{
  "code": "CIG",
  "deviceName": "Diazo Colorimetry, Bilirubin",
  "deviceClass": "II",
  "regulationNumber": "862.1110",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 235,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 123,
    "last12Months": 32
  },
  "reviewDays": {
    "median": 51,
    "sampleSize": 235
  },
  "recalls": {
    "total": 19,
    "recent": [
      {
        "resNumber": "Z-3065-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Siemens Healthcare Diagnostics, Inc.",
        "firmAsPublished": "Siemens Healthcare Diagnostics, Inc.",
        "reason": "During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.",
        "initiated": "2024-07-30"
      },
      {
        "resNumber": "Z-2623-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ortho-Clinical Diagnostics, Inc.",
        "firmAsPublished": "Ortho-Clinical Diagnostics, INc.",
        "reason": "Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.",
        "initiated": "2023-08-05"
      },
      {
        "resNumber": "Z-2874-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ortho-Clinical Diagnostics, Inc.",
        "firmAsPublished": "Ortho-Clinical Diagnostics",
        "reason": "Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides",
        "initiated": "2020-07-13"
      },
      {
        "resNumber": "Z-2875-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ortho-Clinical Diagnostics, Inc.",
        "firmAsPublished": "Ortho-Clinical Diagnostics",
        "reason": "Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides",
        "initiated": "2020-07-13"
      },
      {
        "resNumber": "Z-1540-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Siemens Healthcare Diagnostics, Inc.",
        "firmAsPublished": "Siemens Healthcare Diagnostics, Inc.",
        "reason": "Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy",
        "initiated": "2020-02-13"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251998",
      "deviceName": "Atellica CH Diazo Total Bilirubin (D_TBil)",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2026-02-27",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K223078",
      "deviceName": "Atellica® CH Diazo Direct Bilirubin (D_DBil)",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2023-06-12",
      "dateReceived": "2022-09-30"
    },
    {
      "kNumber": "K222104",
      "deviceName": "Atellica® CH Diazo Total Bilirubin (D_TBil)",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2023-03-20",
      "dateReceived": "2022-07-18"
    },
    {
      "kNumber": "K223324",
      "deviceName": "Total Bilirubin2",
      "applicant": "Abbott Ireland Diagnostics Division",
      "company": "Abbott Ireland Diagnostics Division",
      "decisionDate": "2022-12-29",
      "dateReceived": "2022-10-31"
    },
    {
      "kNumber": "K190807",
      "deviceName": "VITROS XT Chemistry Products TBIL-ALKP Slides",
      "applicant": "Ortho-Clinical Diagnostics, Inc.",
      "company": "Ortho-Clinical Diagnostics, Inc.",
      "decisionDate": "2019-04-26",
      "dateReceived": "2019-03-29"
    },
    {
      "kNumber": "K171401",
      "deviceName": "ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1",
      "applicant": "Elitechgroup",
      "company": "Elitechgroup, Inc.",
      "decisionDate": "2017-07-11",
      "dateReceived": "2017-05-12"
    },
    {
      "kNumber": "K150510",
      "deviceName": "Total Bilirubin",
      "applicant": "Abbott Laboratories",
      "company": "Abbott Laboratories, Inc.",
      "decisionDate": "2015-04-02",
      "dateReceived": "2015-02-27"
    },
    {
      "kNumber": "K131544",
      "deviceName": "COBAS C BILIRUBIN TOTAL GEN.3",
      "applicant": "Roche Diagnostics",
      "company": "Roche Diagnostics Corporation",
      "decisionDate": "2013-07-17",
      "dateReceived": "2013-05-29"
    },
    {
      "kNumber": "K131217",
      "deviceName": "S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN",
      "applicant": "Hitachi Chemical Diagnostics, Inc.",
      "company": "Hitachi Chemical Diagnostics Inc",
      "decisionDate": "2013-06-07",
      "dateReceived": "2013-04-30"
    },
    {
      "kNumber": "K123802",
      "deviceName": "EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT",
      "applicant": "Medica Corp.",
      "company": "Medica Corporation",
      "decisionDate": "2013-03-01",
      "dateReceived": "2012-12-10"
    }
  ],
  "topApplicants": [
    {
      "name": "Em Diagnostic Systems, Inc.",
      "count": 21
    },
    {
      "name": "Abbott Laboratories",
      "count": 15
    },
    {
      "name": "Data Medical Associates, Inc.",
      "count": 10
    },
    {
      "name": "Synermed, Inc.",
      "count": 7
    },
    {
      "name": "Harleco",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Em Diagnostic Systems, Inc.",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Abbott Laboratories, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Data Medical Associates, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Synermed, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Harleco",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 10.046185575787511,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 1,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "CIG (Diazo Colorimetry, Bilirubin): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3ACIG"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACIG"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACIG"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACIG"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACIG"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACIG"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACIG"
    }
  ],
  "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": "2026-08-11T13:51:45.673Z"
}