{
  "code": "LCX",
  "deviceName": "Kit, Test, Pregnancy, Hcg, Over The Counter",
  "deviceClass": "II",
  "regulationNumber": "862.1155",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 226,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 14,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 69,
    "sampleSize": 226
  },
  "recalls": {
    "total": 25,
    "recent": [
      {
        "resNumber": "Z-1184-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "GOLD STAR DISTRIBUTION INC",
        "firmAsPublished": "GOLD STAR DISTRIBUTION INC",
        "reason": "Potential exposure of rodents and rodent activity in the distribution center.",
        "initiated": "2025-12-26"
      },
      {
        "resNumber": "Z-0749-2026",
        "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-0261-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Family Dollar Stores, Llc.",
        "firmAsPublished": "Family Dollar Stores, Llc.",
        "reason": "Products were stored outside of labeled temperature requirements.",
        "initiated": "2023-10-04"
      },
      {
        "resNumber": "Z-0264-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Family Dollar Stores, Llc.",
        "firmAsPublished": "Family Dollar Stores, Llc.",
        "reason": "Products were stored outside of labeled temperature requirements.",
        "initiated": "2023-10-04"
      },
      {
        "resNumber": "Z-0266-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Family Dollar Stores, Llc.",
        "firmAsPublished": "Family Dollar Stores, Llc.",
        "reason": "Products were stored outside of labeled temperature requirements.",
        "initiated": "2023-10-04"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251040",
      "deviceName": "MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test",
      "applicant": "Guangzhou Decheng Biotechnology Co., Ltd.",
      "company": "Guangzhou Decheng Biotechnology Co., Ltd.",
      "decisionDate": "2025-09-09",
      "dateReceived": "2025-04-03"
    },
    {
      "kNumber": "K251053",
      "deviceName": "Shinetell PlusTM Digital Early Pregnancy Test",
      "applicant": "Hangzhou AllTest Biotech Co., Ltd.",
      "company": "Hangzhou AllTest Biotech Co., Ltd.",
      "decisionDate": "2025-07-15",
      "dateReceived": "2025-04-04"
    },
    {
      "kNumber": "K250117",
      "deviceName": "FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette",
      "applicant": "Assure Tech., LLC",
      "company": "Assure Tech. Co., Ltd.",
      "decisionDate": "2025-02-13",
      "dateReceived": "2025-01-16"
    },
    {
      "kNumber": "K242135",
      "deviceName": "Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream",
      "applicant": "Nanjing Synthgene Medical Technology Co., Ltd.",
      "company": "Nanjing Synthgene Medical Technology Co., Ltd.",
      "decisionDate": "2025-01-31",
      "dateReceived": "2024-07-22"
    },
    {
      "kNumber": "K243573",
      "deviceName": "FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream",
      "applicant": "Assure Tech., LLC",
      "company": "Assure Tech. Co., Ltd.",
      "decisionDate": "2025-01-15",
      "dateReceived": "2024-11-19"
    },
    {
      "kNumber": "K241394",
      "deviceName": "iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip",
      "applicant": "Andon Health Co, Ltd.",
      "company": "Andon Health Co, Ltd.",
      "decisionDate": "2024-12-20",
      "dateReceived": "2024-05-16"
    },
    {
      "kNumber": "K240242",
      "deviceName": "HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)",
      "applicant": "Anhui Deepblue Medical Technology Co., Ltd.",
      "company": "Anhui Deepblue Medical Technology Co., Ltd.",
      "decisionDate": "2024-10-11",
      "dateReceived": "2024-01-30"
    },
    {
      "kNumber": "K241978",
      "deviceName": "Shinetell Digital Pregnancy Test",
      "applicant": "Hangzhou AllTest Biotech Co., Ltd.",
      "company": "Hangzhou AllTest Biotech Co., Ltd.",
      "decisionDate": "2024-08-13",
      "dateReceived": "2024-07-05"
    },
    {
      "kNumber": "K240643",
      "deviceName": "MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream",
      "applicant": "Guangzhou Decheng Biotechnology Co., Ltd.",
      "company": "Guangzhou Decheng Biotechnology Co., Ltd.",
      "decisionDate": "2024-06-21",
      "dateReceived": "2024-03-07"
    },
    {
      "kNumber": "K232715",
      "deviceName": "Distinct® Digital Pregnancy Test",
      "applicant": "ACON Laboratories, Inc.",
      "company": "Acon Laboratories, Inc.",
      "decisionDate": "2024-05-31",
      "dateReceived": "2023-09-05"
    }
  ],
  "topApplicants": [
    {
      "name": "Unipath , Ltd.",
      "count": 20
    },
    {
      "name": "ACON Laboratories, Inc.",
      "count": 10
    },
    {
      "name": "Armkel, LLC",
      "count": 10
    },
    {
      "name": "Quidel Corp.",
      "count": 9
    },
    {
      "name": "Syntron Bioresearch, Inc.",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Unipath , Ltd.",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "Acon Laboratories, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Armkel, LLC",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Quidel Corporation",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Syntron Bioresearch, Inc.",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) has one finding. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1184-2026, Z-0749-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1184-2026",
          "Z-0749-2026"
        ],
        "severity": 75
      }
    ],
    "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%3ALCX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALCX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALCX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALCX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALCX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALCX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALCX"
    }
  ],
  "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": "2026-08-11T13:51:45.737Z"
}