{
  "code": "GKZ",
  "deviceName": "Counter, Differential Cell",
  "deviceClass": "II",
  "regulationNumber": "864.5220",
  "panel": "Hematology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 380,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 316,
    "last12Months": 43
  },
  "reviewDays": {
    "median": 105,
    "sampleSize": 380
  },
  "recalls": {
    "total": 244,
    "recent": [
      {
        "resNumber": "Z-0489-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Abbott Laboratories, Inc.",
        "firmAsPublished": "Abbott Laboratories",
        "reason": "Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.",
        "initiated": "2025-09-18"
      },
      {
        "resNumber": "Z-2572-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter Inc.",
        "reason": "Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.",
        "initiated": "2025-08-13"
      },
      {
        "resNumber": "Z-2573-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter Inc.",
        "reason": "Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.",
        "initiated": "2025-08-13"
      },
      {
        "resNumber": "Z-2574-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter Inc.",
        "reason": "Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.",
        "initiated": "2025-08-13"
      },
      {
        "resNumber": "Z-2575-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter Inc.",
        "reason": "Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.",
        "initiated": "2025-08-13"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253212",
      "deviceName": "XR-Series (XR-10, XR-20) Automated Hematology Analyzers",
      "applicant": "Sysmex America, Inc.",
      "company": "Sysmex America, Inc.",
      "decisionDate": "2026-05-27",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K243348",
      "deviceName": "Athelas Home",
      "applicant": "Athelas, Inc.",
      "company": "Athelas, Inc.",
      "decisionDate": "2026-02-06",
      "dateReceived": "2024-10-28"
    },
    {
      "kNumber": "K251249",
      "deviceName": "Tru Hematology Test",
      "applicant": "Truvian Sciences, Inc.",
      "company": "Truvian Sciences, Inc.",
      "decisionDate": "2026-01-16",
      "dateReceived": "2025-04-23"
    },
    {
      "kNumber": "K251371",
      "deviceName": "Sysmex XR-Series (XR-20) Automated Hematology Analyzer",
      "applicant": "Sysmex America, Inc.",
      "company": "Sysmex America, Inc.",
      "decisionDate": "2025-06-25",
      "dateReceived": "2025-05-02"
    },
    {
      "kNumber": "K250943",
      "deviceName": "Sysmex XR-Series (XR-10) Automated Hematology Analyzer",
      "applicant": "Sysmex America, Inc.",
      "company": "Sysmex America, Inc.",
      "decisionDate": "2025-06-25",
      "dateReceived": "2025-03-28"
    },
    {
      "kNumber": "K243283",
      "deviceName": "Alinity h-series System",
      "applicant": "Abbott Laboratories",
      "company": "Abbott Laboratories, Inc.",
      "decisionDate": "2025-02-20",
      "dateReceived": "2024-10-17"
    },
    {
      "kNumber": "K240402",
      "deviceName": "Cito CBC System",
      "applicant": "Cytochip, Inc.",
      "company": "Cytochip, Inc.",
      "decisionDate": "2025-02-03",
      "dateReceived": "2024-02-09"
    },
    {
      "kNumber": "K240252",
      "deviceName": "UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System",
      "applicant": "Beckman Coulter, Inc.",
      "company": "Beckman Coulter, Inc.",
      "decisionDate": "2024-07-05",
      "dateReceived": "2024-01-30"
    },
    {
      "kNumber": "K232946",
      "deviceName": "Yumizen H2500",
      "applicant": "HORIBA ABX SAS",
      "company": "HORIBA ABX SAS",
      "decisionDate": "2024-05-21",
      "dateReceived": "2023-09-20"
    },
    {
      "kNumber": "K240636",
      "deviceName": "HemoScreen Hematology Analyzer",
      "applicant": "Pixcell Medical Technologies",
      "company": "Pixcell Medical Technologies, Ltd.",
      "decisionDate": "2024-05-02",
      "dateReceived": "2024-03-06"
    }
  ],
  "topApplicants": [
    {
      "name": "Beckman Coulter, Inc.",
      "count": 25
    },
    {
      "name": "Abbott Laboratories",
      "count": 24
    },
    {
      "name": "Coulter Corp.",
      "count": 23
    },
    {
      "name": "Sysmex America, Inc.",
      "count": 22
    },
    {
      "name": "Becton Dickinson Immunocytometry Systems",
      "count": 21
    }
  ],
  "topCompanies": [
    {
      "name": "Beckman Coulter, Inc.",
      "count": 28,
      "spellings": 2
    },
    {
      "name": "Abbott Laboratories, Inc.",
      "count": 24,
      "spellings": 1
    },
    {
      "name": "Coulter Corp.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Sysmex America, Inc.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Becton Dickinson Immunocytometry Systems",
      "count": 21,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Truvian Sciences, Inc.",
      "since": "2026-01-16",
      "kNumber": "K251249"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 15.000157660749917,
        "isSufficient": true
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      {
        "month": "2025-02-01",
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        "expectedLow": 0.12753828876579895,
        "expectedHigh": 10.789704416921085,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 11.276891438335607,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 8,
        "expectedLow": 2.0206122926643872,
        "expectedHigh": 11.645556078078082,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 8,
        "expectedLow": 2.289930942654464,
        "expectedHigh": 11.317868767084535,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 7,
        "expectedLow": 3.3186020335193525,
        "expectedHigh": 11.398836621955336,
        "isSufficient": true
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      {
        "month": "2025-07-01",
        "observed": 5,
        "expectedLow": 5.139075320493735,
        "expectedHigh": 17.805752132045228,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 8,
        "expectedLow": 2.198972257893555,
        "expectedHigh": 12.067391489031094,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 7,
        "expectedLow": 2.6694363598146573,
        "expectedHigh": 12.930390967933125,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 3,
        "expectedLow": 2.3727281100154083,
        "expectedHigh": 12.632705601754333,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": 0.28783744800440714,
        "expectedHigh": 10.842019247953191,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 11.536782764928207,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 3,
        "expectedLow": 0.12056022691569483,
        "expectedHigh": 14.564985641801794,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 11.610949882111806,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 13.243554547077203,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "GKZ (Counter, Differential Cell) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0489-2026, Z-2572-2025, Z-2573-2025, Z-2574-2025, Z-2575-2025). 1 first-time filer in the last 12 months, Truvian Sciences, Inc (K251249). The code is crowded, scoring 68 of 100 — 86 companies hold a clearance here and 3 arrived in the last 12 months (GKZ:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0489-2026",
          "Z-2572-2025",
          "Z-2573-2025",
          "Z-2574-2025",
          "Z-2575-2025"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Truvian Sciences, Inc.",
        "recordIds": [
          "K251249"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 68 of 100 — 86 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "GKZ:crowding"
        ],
        "severity": 20
      }
    ],
    "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%3AGKZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGKZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGKZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGKZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGKZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGKZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGKZ"
    }
  ],
  "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": "2026-08-11T13:51:45.704Z"
}