{
  "code": "JPK",
  "deviceName": "Mixture, Hematology Quality Control",
  "deviceClass": "II",
  "regulationNumber": "864.8625",
  "panel": "Hematology",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 192,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 2,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 45,
    "sampleSize": 192
  },
  "recalls": {
    "total": 16,
    "recent": [
      {
        "resNumber": "Z-0999-2023",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "R & D Systems, Inc.",
        "firmAsPublished": "R & D Systems, Inc.",
        "reason": "For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.",
        "initiated": "2022-11-07"
      },
      {
        "resNumber": "Z-0349-2023",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Primus Corporation dba Trinity Biotech",
        "firmAsPublished": "Primus Corporation dba Trinity Biotech",
        "reason": "The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months.  The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.",
        "initiated": "2021-10-05"
      },
      {
        "resNumber": "Z-0350-2023",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Primus Corporation dba Trinity Biotech",
        "firmAsPublished": "Primus Corporation dba Trinity Biotech",
        "reason": "The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months.  Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.",
        "initiated": "2021-10-05"
      },
      {
        "resNumber": "Z-1249-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries Inc",
        "reason": "Product was compromised during shipment.",
        "initiated": "2021-01-25"
      },
      {
        "resNumber": "Z-0562-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Becton, Dickinson and Company, BD Biosciences",
        "firmAsPublished": "Becton, Dickinson and Company, BD Biosciences",
        "reason": "Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.",
        "initiated": "2020-10-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K160590",
      "deviceName": "XN CHECK",
      "applicant": "Streck",
      "company": "Streck",
      "decisionDate": "2016-12-22",
      "dateReceived": "2016-03-01"
    },
    {
      "kNumber": "K160588",
      "deviceName": "XN CHECK BF",
      "applicant": "Streck",
      "company": "Streck",
      "decisionDate": "2016-12-22",
      "dateReceived": "2016-03-01"
    },
    {
      "kNumber": "K160586",
      "deviceName": "XN-L CHECK",
      "applicant": "Streck",
      "company": "Streck",
      "decisionDate": "2016-12-22",
      "dateReceived": "2016-03-01"
    },
    {
      "kNumber": "K160606",
      "deviceName": "BC-5D Hematology Control",
      "applicant": "R&D Systems, Inc.",
      "company": "R & D Systems, Inc.",
      "decisionDate": "2016-09-01",
      "dateReceived": "2016-03-02"
    },
    {
      "kNumber": "K141964",
      "deviceName": "XN CHECK",
      "applicant": "Streck",
      "company": "Streck",
      "decisionDate": "2014-12-05",
      "dateReceived": "2014-07-18"
    },
    {
      "kNumber": "K141957",
      "deviceName": "XN CHECK BF",
      "applicant": "Streck",
      "company": "Streck",
      "decisionDate": "2014-12-05",
      "dateReceived": "2014-07-18"
    },
    {
      "kNumber": "K130962",
      "deviceName": "R&D 5D RETIC HEMATOLOGY CONTROL",
      "applicant": "R&D Systems, Inc.",
      "company": "R & D Systems, Inc.",
      "decisionDate": "2013-07-24",
      "dateReceived": "2013-04-08"
    },
    {
      "kNumber": "K120744",
      "deviceName": "XN CHECK BF",
      "applicant": "Streck",
      "company": "Streck",
      "decisionDate": "2012-10-19",
      "dateReceived": "2012-03-12"
    },
    {
      "kNumber": "K120742",
      "deviceName": "XN CHECK",
      "applicant": "Streck",
      "company": "Streck",
      "decisionDate": "2012-10-19",
      "dateReceived": "2012-03-12"
    },
    {
      "kNumber": "K101578",
      "deviceName": "R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL",
      "applicant": "R&D Systems, Inc.",
      "company": "R & D Systems, Inc.",
      "decisionDate": "2011-04-28",
      "dateReceived": "2010-06-07"
    }
  ],
  "topApplicants": [
    {
      "name": "R&D Systems, Inc.",
      "count": 45
    },
    {
      "name": "Streck Laboratories, Inc.",
      "count": 23
    },
    {
      "name": "Streck",
      "count": 12
    },
    {
      "name": "Beckman Coulter, Inc.",
      "count": 10
    },
    {
      "name": "Coulter Electronics, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "R & D Systems, Inc.",
      "count": 45,
      "spellings": 1
    },
    {
      "name": "Streck Laboratories, Inc.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Streck",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Beckman Coulter, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Coulter Electronics, Inc.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JPK (Mixture, Hematology Quality Control): 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%3AJPK"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJPK"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJPK"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJPK"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJPK"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJPK"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJPK"
    }
  ],
  "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": "2026-08-11T13:51:45.725Z"
}