{
  "code": "CGA",
  "deviceName": "Glucose Oxidase, Glucose",
  "deviceClass": "II",
  "regulationNumber": "862.1345",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 401,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 1396,
    "last12Months": 25
  },
  "reviewDays": {
    "median": 92,
    "sampleSize": 401
  },
  "recalls": {
    "total": 89,
    "recent": [
      {
        "resNumber": "Z-2070-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "HemoCue AB",
        "firmAsPublished": "HemoCue AB",
        "reason": "Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.",
        "initiated": "2025-05-12"
      },
      {
        "resNumber": "Z-1827-2025",
        "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-1702-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Alere San Diego, Inc.",
        "firmAsPublished": "Alere San Diego, Inc.",
        "reason": "There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.",
        "initiated": "2024-03-01"
      },
      {
        "resNumber": "Z-0198-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Randox Laboratories, Limited",
        "firmAsPublished": "Randox Laboratories Ltd.",
        "reason": "RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting  sample re-run conditions when samples are above or below assay range and may result i\nissues with the re-run feature conditions when incorrectly. Potential to report incorrectly.",
        "initiated": "2023-09-06"
      },
      {
        "resNumber": "Z-0201-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Randox Laboratories, Limited",
        "firmAsPublished": "Randox Laboratories Ltd.",
        "reason": "RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting  sample re-run conditions when samples are above or below assay range and may result i\nissues with the re-run feature conditions when incorrectly. Potential to report incorrectly.",
        "initiated": "2023-09-06"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252488",
      "deviceName": "ABL90 FLEX PLUS System",
      "applicant": "Radiometer Medicals Aps",
      "company": "Radiometer Medicals Aps",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-08-08"
    },
    {
      "kNumber": "K210933",
      "deviceName": "YSI 2900C Biochemistry Analyzer",
      "applicant": "Ysi, Inc.",
      "company": "YSI INCORPORATED",
      "decisionDate": "2024-09-30",
      "dateReceived": "2021-03-29"
    },
    {
      "kNumber": "K220328",
      "deviceName": "EasyStat 300",
      "applicant": "Medica Corporation",
      "company": "Medica Corporation",
      "decisionDate": "2024-07-26",
      "dateReceived": "2022-02-04"
    },
    {
      "kNumber": "K223179",
      "deviceName": "Cholestech LDX ™ System",
      "applicant": "Alere San Diego, Inc.",
      "company": "Alere San Diego, Inc.",
      "decisionDate": "2023-09-20",
      "dateReceived": "2022-10-11"
    },
    {
      "kNumber": "K223755",
      "deviceName": "i-STAT G cartridge with the i-STAT 1 System",
      "applicant": "Abbott Point of Care, Inc.",
      "company": "Abbott Point Of Care Inc.",
      "decisionDate": "2023-09-11",
      "dateReceived": "2022-12-15"
    },
    {
      "kNumber": "K223710",
      "deviceName": "i-STAT CG8+ cartridge with the i-STAT 1 System",
      "applicant": "Abbott Point of Care, Inc.",
      "company": "Abbott Point Of Care Inc.",
      "decisionDate": "2023-07-28",
      "dateReceived": "2022-12-12"
    },
    {
      "kNumber": "K223090",
      "deviceName": "GEM Premier ChemSTAT",
      "applicant": "Instrumentation Laboratory CO",
      "company": "Instrumentation Laboratory",
      "decisionDate": "2023-01-27",
      "dateReceived": "2022-09-30"
    },
    {
      "kNumber": "K203549",
      "deviceName": "Nova Primary Glucose Analyzer System",
      "applicant": "Nova Biomedical Corporation",
      "company": "Nova Biomedical Corporation",
      "decisionDate": "2022-10-18",
      "dateReceived": "2020-12-04"
    },
    {
      "kNumber": "K210958",
      "deviceName": "i-STAT CHEM8+ cartridge with the i-STAT 1 System",
      "applicant": "Abbott Point of Care, Inc.",
      "company": "Abbott Point Of Care Inc.",
      "decisionDate": "2021-08-13",
      "dateReceived": "2021-03-31"
    },
    {
      "kNumber": "K200349",
      "deviceName": "Stat Profile Prime Plus Analyzer System",
      "applicant": "Nova Biomedical Corporation",
      "company": "Nova Biomedical Corporation",
      "decisionDate": "2020-03-13",
      "dateReceived": "2020-02-12"
    }
  ],
  "topApplicants": [
    {
      "name": "Lifescan, Inc.",
      "count": 21
    },
    {
      "name": "Boehringer Mannheim Corp.",
      "count": 17
    },
    {
      "name": "Apex BioTechnology Corp.",
      "count": 14
    },
    {
      "name": "Miles Laboratories, Inc.",
      "count": 12
    },
    {
      "name": "Medisense, Inc.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Lifescan Inc",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Boehringer Mannheim Corp.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Apex BioTechnology Corp.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Miles Laboratories, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Medisense, Inc.",
      "count": 11,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Radiometer Medicals Aps",
      "since": "2026-05-01",
      "kNumber": "K252488"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 845,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 39,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 7,
        "expectedLow": 3.010756410045184,
        "expectedHigh": 30.90284956011509,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 8,
        "expectedLow": 0.02051422048809427,
        "expectedHigh": 24.18722761724426,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 25.501143830615863,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 23.604539424701336,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 22.018011057152858,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 21.05180994488334,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 33.542821685876675,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 22.196058330296736,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": 0,
        "expectedHigh": 21.62464151055815,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 20.419533170893512,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 12.91108309530914,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 14.205898661421491,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 12.417904573965165,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 9.849255726863886,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 8.728280189087137,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "CGA (Glucose Oxidase, Glucose) has two findings, most consequential first. 1 first-time filer in the last 12 months, Radiometer Medicals Aps (K252488). The code is crowded, scoring 71 of 100 — 179 companies hold a clearance here and 1 arrived in the last 12 months (CGA:crowding).",
    "severity": 41,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Radiometer Medicals Aps",
        "recordIds": [
          "K252488"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 71 of 100 — 179 companies hold a clearance here and 1 arrived in the last 12 months",
        "recordIds": [
          "CGA: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%3ACGA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACGA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACGA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACGA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACGA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACGA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACGA"
    }
  ],
  "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": "2026-08-11T13:51:45.671Z"
}