{
  "code": "JJY",
  "deviceName": "Multi-Analyte Controls, All Kinds (Assayed)",
  "deviceClass": "I",
  "regulationNumber": "862.1660",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 673,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 17,
    "last12Months": 3
  },
  "reviewDays": {
    "median": 45,
    "sampleSize": 673
  },
  "recalls": {
    "total": 91,
    "recent": [
      {
        "resNumber": "Z-0538-2026",
        "status": "Open, Classified",
        "recallClass": "Class III",
        "firm": "POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC",
        "firmAsPublished": "POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC",
        "reason": "A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.",
        "initiated": "2025-10-06"
      },
      {
        "resNumber": "Z-0415-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Microgenics Corporation",
        "firmAsPublished": "Microgenics Corporation",
        "reason": "The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.",
        "initiated": "2025-10-01"
      },
      {
        "resNumber": "Z-1824-2025",
        "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-1838-2025",
        "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-1839-2025",
        "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": "K162530",
      "deviceName": "Multichem IA Plus",
      "applicant": "Techno-Path Manufacturing",
      "company": "TECHNO-PATH MANUFACTURING LTD.",
      "decisionDate": "2017-03-31",
      "dateReceived": "2016-09-09"
    },
    {
      "kNumber": "K163629",
      "deviceName": "Audit MicroControls Linearity FD Tumor Markers II",
      "applicant": "Aalto Scientific, Ltd.",
      "company": "Aalto Scientific, Ltd.",
      "decisionDate": "2017-03-10",
      "dateReceived": "2016-12-22"
    },
    {
      "kNumber": "K163015",
      "deviceName": "Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak",
      "applicant": "Bio-Rad Laboratories",
      "company": "Bio-Rad Laboratories, Inc.",
      "decisionDate": "2017-01-10",
      "dateReceived": "2016-10-28"
    },
    {
      "kNumber": "K153712",
      "deviceName": "VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit",
      "applicant": "Radiometer America, Inc.",
      "company": "Radiometer America Inc",
      "decisionDate": "2016-01-28",
      "dateReceived": "2015-12-24"
    },
    {
      "kNumber": "K150300",
      "deviceName": "Liquichek Cardiac Markers Plus Control LT",
      "applicant": "Bio-Rad Laboratories",
      "company": "Bio-Rad Laboratories, Inc.",
      "decisionDate": "2015-12-11",
      "dateReceived": "2015-02-06"
    },
    {
      "kNumber": "K142964",
      "deviceName": "VALIDATE Anemia Calibration Verification/ Linearity Test Kit",
      "applicant": "Maine Standards Company, LLC",
      "company": "Maine Standards Company, LLC",
      "decisionDate": "2015-04-30",
      "dateReceived": "2014-10-14"
    },
    {
      "kNumber": "K143379",
      "deviceName": "Liquichek Maternal Serum II Control",
      "applicant": "Bio-Rad Laboratories",
      "company": "Bio-Rad Laboratories, Inc.",
      "decisionDate": "2015-03-13",
      "dateReceived": "2014-11-25"
    },
    {
      "kNumber": "K143573",
      "deviceName": "Audit MicroControls Linearity FD Tumor Markers II",
      "applicant": "Aalto Scientific, Ltd.",
      "company": "Aalto Scientific, Ltd.",
      "decisionDate": "2015-01-16",
      "dateReceived": "2014-12-17"
    },
    {
      "kNumber": "K140971",
      "deviceName": "LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.",
      "applicant": "Randox Laboratories Limited",
      "company": "Randox Laboratories, Limited",
      "decisionDate": "2014-12-08",
      "dateReceived": "2014-04-16"
    },
    {
      "kNumber": "K142978",
      "deviceName": "Audit MicroControls Linearity LQ Special Diabetes",
      "applicant": "Aalto Scientific, Ltd.",
      "company": "Aalto Scientific, Ltd.",
      "decisionDate": "2014-11-20",
      "dateReceived": "2014-10-15"
    }
  ],
  "topApplicants": [
    {
      "name": "Bio-Rad",
      "count": 61
    },
    {
      "name": "Medical Analysis Systems, Inc.",
      "count": 31
    },
    {
      "name": "Cliniqa Corporation",
      "count": 22
    },
    {
      "name": "Aalto Scientific, Ltd.",
      "count": 19
    },
    {
      "name": "Bio-Rad Laboratories",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Bio-Rad",
      "count": 61,
      "spellings": 1
    },
    {
      "name": "Medical Analysis Systems, Inc.",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Bio-Rad Laboratories, Inc.",
      "count": 26,
      "spellings": 2
    },
    {
      "name": "Cliniqa Corporation",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Roche Diagnostics Corporation",
      "count": 22,
      "spellings": 2
    }
  ],
  "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": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JJY (Multi-Analyte Controls, All Kinds (Assayed)) has one finding. 2 recalls opened in the last 12 months and not yet terminated (Class II, Class III) (Z-0538-2026, Z-0415-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II, Class III)",
        "recordIds": [
          "Z-0538-2026",
          "Z-0415-2026"
        ],
        "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%3AJJY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJJY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJJY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJJY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJJY"
    }
  ],
  "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": "2026-08-11T13:51:45.721Z"
}