{
  "code": "DKZ",
  "deviceName": "Enzyme Immunoassay, Amphetamine",
  "deviceClass": "II",
  "regulationNumber": "862.3100",
  "panel": "Clinical Toxicology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 225,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 8,
    "last12Months": 1
  },
  "reviewDays": {
    "median": 76,
    "sampleSize": 225
  },
  "recalls": {
    "total": 24,
    "recent": [
      {
        "resNumber": "Z-1589-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.",
        "initiated": "2022-05-25"
      },
      {
        "resNumber": "Z-3048-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ameditech, Inc.",
        "firmAsPublished": "Ameditech Inc",
        "reason": "Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.",
        "initiated": "2020-08-18"
      },
      {
        "resNumber": "Z-3049-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ameditech, Inc.",
        "firmAsPublished": "Ameditech Inc",
        "reason": "Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.",
        "initiated": "2020-08-18"
      },
      {
        "resNumber": "Z-3050-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ameditech, Inc.",
        "firmAsPublished": "Ameditech Inc",
        "reason": "Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.",
        "initiated": "2020-08-18"
      },
      {
        "resNumber": "Z-0418-2018",
        "status": "Completed",
        "recallClass": "Class II",
        "firm": "Alere San Diego, Inc.",
        "firmAsPublished": "Alere San Diego, Inc.",
        "reason": "The recalled lots have demonstrated unexpected false positive THC results.",
        "initiated": "2017-11-14"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K240670",
      "deviceName": "DRI Ecstasy Plus Assay",
      "applicant": "Microgenics Corporation",
      "company": "Microgenics Corporation",
      "decisionDate": "2024-10-30",
      "dateReceived": "2024-03-11"
    },
    {
      "kNumber": "K233019",
      "deviceName": "AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx",
      "applicant": "Hangzhou AllTest Biotech Co., Ltd.",
      "company": "Hangzhou AllTest Biotech Co., Ltd.",
      "decisionDate": "2023-12-13",
      "dateReceived": "2023-09-22"
    },
    {
      "kNumber": "K231137",
      "deviceName": "Xenta Drug Screen Cup, Xenta Drug Screen Dipcard",
      "applicant": "Xenta Biomedical Science Co., Ltd.",
      "company": "Xenta Biomedical Science Co., Ltd.",
      "decisionDate": "2023-05-19",
      "dateReceived": "2023-04-21"
    },
    {
      "kNumber": "K200363",
      "deviceName": "Quidel Triage® TOX Drug Screen, 94600",
      "applicant": "Quidel Cardiovascular, Inc.",
      "company": "QUIDEL CARDIOVASCULAR INC",
      "decisionDate": "2020-03-11",
      "dateReceived": "2020-02-14"
    },
    {
      "kNumber": "K191099",
      "deviceName": "Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel",
      "applicant": "Atlas Medical",
      "company": "Atlas Medical",
      "decisionDate": "2019-10-03",
      "dateReceived": "2019-04-25"
    },
    {
      "kNumber": "K182719",
      "deviceName": "Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro",
      "applicant": "Quidel Cardiovascular, Inc.",
      "company": "QUIDEL CARDIOVASCULAR INC",
      "decisionDate": "2019-06-19",
      "dateReceived": "2018-09-28"
    },
    {
      "kNumber": "K182738",
      "deviceName": "Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)",
      "applicant": "Hangzhou AllTest Biotech Co., Ltd.",
      "company": "Hangzhou AllTest Biotech Co., Ltd.",
      "decisionDate": "2019-03-27",
      "dateReceived": "2018-09-28"
    },
    {
      "kNumber": "K180879",
      "deviceName": "BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use",
      "applicant": "Shanghai Venture Bio-Tech Co., Ltd.",
      "company": "Shanghai Venture Bio-Tech Co., Ltd.",
      "decisionDate": "2018-12-14",
      "dateReceived": "2018-04-03"
    },
    {
      "kNumber": "K181945",
      "deviceName": "QuickScreen Pro Multi Drug Screening Test, Model 9395Z",
      "applicant": "Phamatech, Inc.",
      "company": "Phamatech, Inc.",
      "decisionDate": "2018-10-18",
      "dateReceived": "2018-07-20"
    },
    {
      "kNumber": "K173303",
      "deviceName": "INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)",
      "applicant": "Alfa Scientific Designs, Inc.",
      "company": "Alfa Scientific Designs, Inc.",
      "decisionDate": "2018-02-23",
      "dateReceived": "2017-10-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Roche Diagnostic Systems, Inc.",
      "count": 17
    },
    {
      "name": "Syva Co.",
      "count": 13
    },
    {
      "name": "American Bio Medica Corp.",
      "count": 9
    },
    {
      "name": "Roche Diagnostics Corp.",
      "count": 9
    },
    {
      "name": "Ucp Biosciences, Inc.",
      "count": 9
    }
  ],
  "topCompanies": [
    {
      "name": "Roche Diagnostic Systems, Inc.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Syva Co.",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Roche Diagnostics Corporation",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "American Bio Medica Corp.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Ucp Biosciences, Inc.",
      "count": 9,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "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": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "DKZ (Enzyme Immunoassay, Amphetamine): 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%3ADKZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADKZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADKZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADKZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADKZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADKZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADKZ"
    }
  ],
  "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": "2026-08-11T13:51:45.675Z"
}