{
  "code": "JLW",
  "deviceName": "Radioimmunoassay, Thyroid-Stimulating Hormone",
  "deviceClass": "II",
  "regulationNumber": "862.1690",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 242,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 422,
    "last12Months": 62
  },
  "reviewDays": {
    "median": 57,
    "sampleSize": 242
  },
  "recalls": {
    "total": 46,
    "recent": [
      {
        "resNumber": "Z-0752-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GET TESTED INTERNATIONAL AB",
        "firmAsPublished": "GET TESTED INTERNATIONAL AB",
        "reason": "Distribution without premarket approval/clearance.",
        "initiated": "2025-11-03"
      },
      {
        "resNumber": "Z-0216-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already \"In Progress\" using the same \"Sample ID number\". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.",
        "initiated": "2025-09-19"
      },
      {
        "resNumber": "Z-1913-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.",
        "initiated": "2025-04-23"
      },
      {
        "resNumber": "Z-1926-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.",
        "initiated": "2025-04-23"
      },
      {
        "resNumber": "Z-0094-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter, Inc.",
        "reason": "Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.",
        "initiated": "2024-08-28"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251543",
      "deviceName": "Atellica® IM TSH3-Ultra II (TSH3ULII)",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2026-02-06",
      "dateReceived": "2025-05-20"
    },
    {
      "kNumber": "K243570",
      "deviceName": "Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)",
      "applicant": "Siemens Healthcare Diagnostics",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2025-04-25",
      "dateReceived": "2024-11-18"
    },
    {
      "kNumber": "K234091",
      "deviceName": "Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0",
      "applicant": "Genalyte, Inc.",
      "company": "Genalyte, Inc.",
      "decisionDate": "2024-07-22",
      "dateReceived": "2023-12-26"
    },
    {
      "kNumber": "K233050",
      "deviceName": "ADVIA Centaur®  TSH3-Ultra II (TSH3ULII)",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2024-04-04",
      "dateReceived": "2023-09-25"
    },
    {
      "kNumber": "K222116",
      "deviceName": "Atellica® CI Analyzer,  Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)",
      "applicant": "Siemens Healthcare Diagnostics, Inc.",
      "company": "Siemens Healthcare Diagnostics, Inc.",
      "decisionDate": "2023-07-13",
      "dateReceived": "2022-07-18"
    },
    {
      "kNumber": "K221225",
      "deviceName": "Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer",
      "applicant": "Beckman Coulter, Inc.",
      "company": "Beckman Coulter, Inc.",
      "decisionDate": "2022-11-10",
      "dateReceived": "2022-04-28"
    },
    {
      "kNumber": "K190773",
      "deviceName": "Elecsys TSH",
      "applicant": "Roche Diagnostics",
      "company": "Roche Diagnostics Corporation",
      "decisionDate": "2019-04-16",
      "dateReceived": "2019-03-26"
    },
    {
      "kNumber": "K170232",
      "deviceName": "AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer",
      "applicant": "Boditech Med, Inc.",
      "company": "Boditech Med, Inc.",
      "decisionDate": "2017-10-13",
      "dateReceived": "2017-01-25"
    },
    {
      "kNumber": "K171103",
      "deviceName": "Lumipulse G TSH-III Immunoreaction Cartridges",
      "applicant": "Fujirebio Diagnostics,Inc.",
      "company": "Fujirebio Diagnostics, Inc.",
      "decisionDate": "2017-07-28",
      "dateReceived": "2017-04-13"
    },
    {
      "kNumber": "K162698",
      "deviceName": "MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer",
      "applicant": "Shenzhen New Industries Biomedical Engineering Co., Ltd.",
      "company": "Shenzhen New Industries Biomedical Engineering Co., Ltd.",
      "decisionDate": "2017-07-14",
      "dateReceived": "2016-09-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Abbott Laboratories",
      "count": 10
    },
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 9
    },
    {
      "name": "Bio-Rad",
      "count": 9
    },
    {
      "name": "Diagnostic Products Corp.",
      "count": 8
    },
    {
      "name": "Micromedic Systems",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Abbott Laboratories, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Siemens Healthcare Diagnostics, Inc.",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "Bd Becton Dickinson Vacutainer Systems Preanalytic",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Bio-Rad",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Diagnostic Products Corp.",
      "count": 8,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 23.200273808280045,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 19.640518422015774,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 13,
        "expectedLow": 0,
        "expectedHigh": 21.07503572317067,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 17,
        "expectedLow": 0,
        "expectedHigh": 23.080599583919824,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 10,
        "expectedLow": 2.551238203763917,
        "expectedHigh": 19.71670669042218,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 9,
        "expectedLow": 2.302813581692068,
        "expectedHigh": 20.08608499742845,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 6,
        "expectedLow": 2.6500587851397492,
        "expectedHigh": 30.662471949454524,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 2,
        "expectedLow": 0,
        "expectedHigh": 20.641799056224322,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 20.224937556824667,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 18.09183527697196,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 16.29382642267337,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 17.843061394407645,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 20,
        "expectedLow": 0,
        "expectedHigh": 19.8643264431773,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 20.711823842928617,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 21.627288879318094,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "JLW (Radioimmunoassay, Thyroid-Stimulating Hormone) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0752-2026, Z-0216-2026). The code is crowded, scoring 60 of 100 — 134 companies hold a clearance here and 1 arrived in the last 12 months (JLW:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0752-2026",
          "Z-0216-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 60 of 100 — 134 companies hold a clearance here and 1 arrived in the last 12 months",
        "recordIds": [
          "JLW: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%3AJLW"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJLW"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJLW"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJLW"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJLW"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJLW"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJLW"
    }
  ],
  "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": "2026-08-11T13:51:45.723Z"
}