{
  "code": "JJQ",
  "deviceName": "Colorimeter, Photometer, Spectrophotometer For Clinical Use",
  "deviceClass": "I",
  "regulationNumber": "862.2300",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 258,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 42,
    "last12Months": 15
  },
  "reviewDays": {
    "median": 46,
    "sampleSize": 258
  },
  "recalls": {
    "total": 17,
    "recent": [
      {
        "resNumber": "Z-0240-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Becton, Dickinson and Company",
        "firmAsPublished": "Becton Dickinson & Co.",
        "reason": "Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.",
        "initiated": "2025-09-23"
      },
      {
        "resNumber": "Z-0269-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.",
        "initiated": "2022-10-03"
      },
      {
        "resNumber": "Z-2660-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Tecan US, Inc.",
        "firmAsPublished": "Tecan US, Inc.",
        "reason": "The batteries have the potential to overheating, melt or char.",
        "initiated": "2016-07-25"
      },
      {
        "resNumber": "Z-2661-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Tecan US, Inc.",
        "firmAsPublished": "Tecan US, Inc.",
        "reason": "The batteries have the potential to overheating, melt or char.",
        "initiated": "2016-07-25"
      },
      {
        "resNumber": "Z-2662-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Tecan US, Inc.",
        "firmAsPublished": "Tecan US, Inc.",
        "reason": "The batteries have the potential to overheating, melt or char.",
        "initiated": "2016-07-25"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K013371",
      "deviceName": "UBIT-IR300 INFRARED SPECTROMETRY SYSTEM",
      "applicant": "Otsuka Pharmaceutical Co., Ltd.",
      "company": "Otsuka Pharmaceutical Co., Ltd.",
      "decisionDate": "2001-12-21",
      "dateReceived": "2001-10-11"
    },
    {
      "kNumber": "K980120",
      "deviceName": "DIGENE DML 2000 MICROPLATE LUMINOMETER",
      "applicant": "Digene Corp.",
      "company": "Digene Corp.",
      "decisionDate": "1998-02-06",
      "dateReceived": "1998-01-13"
    },
    {
      "kNumber": "K973938",
      "deviceName": "ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER",
      "applicant": "Sfri, Inc.",
      "company": "Sfri, Inc.",
      "decisionDate": "1998-02-04",
      "dateReceived": "1997-10-15"
    },
    {
      "kNumber": "K974762",
      "deviceName": "STAT TRACKS",
      "applicant": "Awareness Technology, Inc.",
      "company": "Awareness Technology, Inc.",
      "decisionDate": "1998-01-28",
      "dateReceived": "1997-12-19"
    },
    {
      "kNumber": "K962113",
      "deviceName": "ANTHOS PHACTS VERSION MICROPLATE READER",
      "applicant": "Columbia Bioscience, Inc.",
      "company": "Columbia Bioscience, Inc.",
      "decisionDate": "1996-11-05",
      "dateReceived": "1996-05-31"
    },
    {
      "kNumber": "K961183",
      "deviceName": "CBI 7520 READER",
      "applicant": "Columbia Bioscience, Inc.",
      "company": "Columbia Bioscience, Inc.",
      "decisionDate": "1996-08-02",
      "dateReceived": "1996-03-26"
    },
    {
      "kNumber": "K962166",
      "deviceName": "ORIGEN ANALYZER",
      "applicant": "Igen, Inc.",
      "company": "Igen, Inc.",
      "decisionDate": "1996-07-31",
      "dateReceived": "1996-06-04"
    },
    {
      "kNumber": "K955077",
      "deviceName": "ANTHOS 2010 READER",
      "applicant": "Anthos Labtec, Inc.",
      "company": "Anthos Labtec, Inc.",
      "decisionDate": "1995-12-04",
      "dateReceived": "1995-11-06"
    },
    {
      "kNumber": "K953710",
      "deviceName": "ELX808 AUTOMATED MICROPLATE READERS",
      "applicant": "Bio-Tek Instruments, Inc.",
      "company": "Bio-Tek Instruments, Inc.",
      "decisionDate": "1995-10-25",
      "dateReceived": "1995-08-09"
    },
    {
      "kNumber": "K953572",
      "deviceName": "ELX800UV",
      "applicant": "Bio-Tek Instruments, Inc.",
      "company": "Bio-Tek Instruments, Inc.",
      "decisionDate": "1995-10-19",
      "dateReceived": "1995-07-31"
    }
  ],
  "topApplicants": [
    {
      "name": "Dynatech Laboratories, Inc.",
      "count": 15
    },
    {
      "name": "Bio-Tek Instruments, Inc.",
      "count": 14
    },
    {
      "name": "Awareness Technology, Inc.",
      "count": 8
    },
    {
      "name": "Lkb Instruments, Inc.",
      "count": 7
    },
    {
      "name": "Varian Assoc., Inc.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Dynatech Laboratories, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Bio-Tek Instruments, Inc.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Awareness Technology, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Lkb Instruments, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Varian Assoc., Inc.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0240-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0240-2026"
        ],
        "severity": 75
      }
    ],
    "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%3AJJQ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJQ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJQ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJJQ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJJQ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJJQ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJJQ"
    }
  ],
  "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": "2026-08-11T13:51:45.720Z"
}