{
  "code": "NBW",
  "deviceName": "System, Test, Blood Glucose, Over The Counter",
  "deviceClass": "II",
  "regulationNumber": "862.1345",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 509,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 17504,
    "last12Months": 3029
  },
  "reviewDays": {
    "median": 153,
    "sampleSize": 509
  },
  "recalls": {
    "total": 137,
    "recent": [
      {
        "resNumber": "Z-1545-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Trividia Health, Inc.",
        "firmAsPublished": "Trividia Health, Inc.",
        "reason": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.",
        "initiated": "2026-02-06"
      },
      {
        "resNumber": "Z-1546-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Trividia Health, Inc.",
        "firmAsPublished": "Trividia Health, Inc.",
        "reason": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.",
        "initiated": "2026-02-06"
      },
      {
        "resNumber": "Z-1547-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Trividia Health, Inc.",
        "firmAsPublished": "Trividia Health, Inc.",
        "reason": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.",
        "initiated": "2026-02-06"
      },
      {
        "resNumber": "Z-1548-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Trividia Health, Inc.",
        "firmAsPublished": "Trividia Health, Inc.",
        "reason": "The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.",
        "initiated": "2026-02-06"
      },
      {
        "resNumber": "Z-0413-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Trividia Health, Inc.",
        "firmAsPublished": "Trividia Health, Inc.",
        "reason": "Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.",
        "initiated": "2025-10-07"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262116",
      "deviceName": "TRUE METRIX Self Monitoring Blood Glucose System",
      "applicant": "Trividia Health, Inc.",
      "company": "Trividia Health, Inc.",
      "decisionDate": "2026-07-23",
      "dateReceived": "2026-06-23"
    },
    {
      "kNumber": "K250085",
      "deviceName": "On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System",
      "applicant": "ACON Laboratories, Inc.",
      "company": "Acon Laboratories, Inc.",
      "decisionDate": "2025-10-10",
      "dateReceived": "2025-01-13"
    },
    {
      "kNumber": "K243060",
      "deviceName": "TeleRPM Gen2 Blood Glucose Monitoring System",
      "applicant": "Guangdong Transtek Medical Electronics Co., Ltd.",
      "company": "Guangdong Transtek Medical Electronics Co., Ltd.",
      "decisionDate": "2025-01-30",
      "dateReceived": "2024-09-27"
    },
    {
      "kNumber": "K240637",
      "deviceName": "RIGHTEST Blood Glucose Monitoring System Max Tel",
      "applicant": "Bionime Corporation",
      "company": "Bionime Corporation",
      "decisionDate": "2024-11-04",
      "dateReceived": "2024-03-06"
    },
    {
      "kNumber": "K240640",
      "deviceName": "Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System",
      "applicant": "Sejoy Biomedical Co., Ltd.",
      "company": "Sejoy Biomedical Co., Ltd.",
      "decisionDate": "2024-10-08",
      "dateReceived": "2024-03-06"
    },
    {
      "kNumber": "K241787",
      "deviceName": "CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System",
      "applicant": "Ascensia Diabetes Care U.S., Inc.",
      "company": "Ascensia Diabetes Care U.S., Inc.",
      "decisionDate": "2024-08-27",
      "dateReceived": "2024-06-21"
    },
    {
      "kNumber": "K222126",
      "deviceName": "VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System",
      "applicant": "Vivachek Biotech (Hangzhou) Co., Ltd.",
      "company": "Vivachek Biotech (Hangzhou) Co., Ltd.",
      "decisionDate": "2024-08-16",
      "dateReceived": "2022-07-18"
    },
    {
      "kNumber": "K241304",
      "deviceName": "WaveSense Jazz Blood Glucose Monitoring System",
      "applicant": "Agamatrix",
      "company": "Agamatrix, Inc.",
      "decisionDate": "2024-06-06",
      "dateReceived": "2024-05-09"
    },
    {
      "kNumber": "K231679",
      "deviceName": "CONTOUR® PLUS BLUE Blood Glucose Monitoring System",
      "applicant": "Ascensia Diabetes Care",
      "company": "Ascensia Diabetes Care",
      "decisionDate": "2024-02-23",
      "dateReceived": "2023-06-09"
    },
    {
      "kNumber": "K231192",
      "deviceName": "RIGHTEST Blood Glucose Monitoring System Max Tel",
      "applicant": "Bionime Corporation",
      "company": "Bionime Corporation",
      "decisionDate": "2024-01-19",
      "dateReceived": "2023-04-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Taidoc Technology Corporation",
      "count": 65
    },
    {
      "name": "I-Sens, Inc.",
      "count": 21
    },
    {
      "name": "Abbott Diabetes Care, Inc.",
      "count": 18
    },
    {
      "name": "Apex BioTechnology Corp.",
      "count": 18
    },
    {
      "name": "Bionime Corporation",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Taidoc Technology Corporation",
      "count": 65,
      "spellings": 1
    },
    {
      "name": "I-Sens, Inc.",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Abbott Diabetes Care, Inc.",
      "count": 19,
      "spellings": 2
    },
    {
      "name": "Roche Diagnostics Corporation",
      "count": 19,
      "spellings": 3
    },
    {
      "name": "Apex BioTechnology Corp.",
      "count": 18,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 688,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 671,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 736,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 509,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 656,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 594,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 447,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 575,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 466,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 658,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 553,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 453,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 657,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 544,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 374,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 566,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 473,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 469,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 507,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 479,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 487,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 377,
        "expectedLow": 274.3683160026369,
        "expectedHigh": 623.3708055661133,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 368,
        "expectedLow": 232.44929186087913,
        "expectedHigh": 509.71028357066194,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 361,
        "expectedLow": 263.58124793401663,
        "expectedHigh": 562.4809376594786,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 369,
        "expectedLow": 250.9850309599228,
        "expectedHigh": 576.4217656620008,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 404,
        "expectedLow": 287.34678930976617,
        "expectedHigh": 459.29037819502787,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 389,
        "expectedLow": 322.48404655526593,
        "expectedHigh": 467.48943438071416,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 376,
        "expectedLow": 506.92788314770576,
        "expectedHigh": 733.9276343608623,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 415,
        "expectedLow": 282.4727063470168,
        "expectedHigh": 541.997740859123,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 413,
        "expectedLow": 296.570550265919,
        "expectedHigh": 573.3141196684876,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 428,
        "expectedLow": 287.3231370271354,
        "expectedHigh": 563.8483391287758,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 361,
        "expectedLow": 263.71657562368864,
        "expectedHigh": 504.86232554076975,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 363,
        "expectedLow": 290.68184620925393,
        "expectedHigh": 545.2757100347754,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 491,
        "expectedLow": 318.4345161519,
        "expectedHigh": 605.777000782608,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 370,
        "expectedLow": 278.3735762957639,
        "expectedHigh": 519.5976667360914,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 298,
        "expectedLow": 304.0411749091028,
        "expectedHigh": 549.836087260994,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "NBW (System, Test, Blood Glucose, Over The Counter) has two findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-1545-2026, Z-1546-2026, Z-1547-2026, Z-1548-2026, Z-0413-2026). The code is crowded, scoring 62 of 100 — 113 companies hold a clearance here and 2 arrived in the last 12 months (NBW:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class I, Class II)",
        "recordIds": [
          "Z-1545-2026",
          "Z-1546-2026",
          "Z-1547-2026",
          "Z-1548-2026",
          "Z-0413-2026"
        ],
        "severity": 85
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 62 of 100 — 113 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "NBW: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%3ANBW"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANBW"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANBW"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ANBW"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ANBW"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ANBW"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ANBW"
    }
  ],
  "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": "2026-08-11T13:51:45.748Z"
}