{
  "code": "JTO",
  "deviceName": "Discs, Strips And Reagents, Microorganism Differentiation",
  "deviceClass": "I",
  "regulationNumber": "866.2660",
  "panel": "Microbiology",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 244,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 20,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 39,
    "sampleSize": 244
  },
  "recalls": {
    "total": 21,
    "recent": [
      {
        "resNumber": "Z-0783-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "bioMerieux, Inc.",
        "firmAsPublished": "Biomerieux Inc",
        "reason": "As the temperature and time out of range was exceeded, product performances cannot be guaranteed",
        "initiated": "2022-11-09"
      },
      {
        "resNumber": "Z-0805-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "bioMerieux, Inc.",
        "firmAsPublished": "Biomerieux Inc",
        "reason": "As the temperature and time out of range was exceeded, product performances cannot be guaranteed",
        "initiated": "2022-11-09"
      },
      {
        "resNumber": "Z-0806-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "bioMerieux, Inc.",
        "firmAsPublished": "Biomerieux Inc",
        "reason": "As the temperature and time out of range was exceeded, product performances cannot be guaranteed",
        "initiated": "2022-11-09"
      },
      {
        "resNumber": "Z-0807-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "bioMerieux, Inc.",
        "firmAsPublished": "Biomerieux Inc",
        "reason": "As the temperature and time out of range was exceeded, product performances cannot be guaranteed",
        "initiated": "2022-11-09"
      },
      {
        "resNumber": "Z-0808-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "bioMerieux, Inc.",
        "firmAsPublished": "Biomerieux Inc",
        "reason": "As the temperature and time out of range was exceeded, product performances cannot be guaranteed",
        "initiated": "2022-11-09"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K050352",
      "deviceName": "IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT",
      "applicant": "Ameritek Research, LLC",
      "company": "Ameritek Research, LLC",
      "decisionDate": "2005-09-01",
      "dateReceived": "2005-02-11"
    },
    {
      "kNumber": "K970832",
      "deviceName": "PYR SWAB",
      "applicant": "Remel, Inc.",
      "company": "Remel, Inc.",
      "decisionDate": "1997-04-24",
      "dateReceived": "1997-03-07"
    },
    {
      "kNumber": "K970834",
      "deviceName": "GRAM SWAB",
      "applicant": "Remel, Inc.",
      "company": "Remel, Inc.",
      "decisionDate": "1997-04-17",
      "dateReceived": "1997-03-07"
    },
    {
      "kNumber": "K970833",
      "deviceName": "INDOLE SWAB",
      "applicant": "Remel, Inc.",
      "company": "Remel, Inc.",
      "decisionDate": "1997-04-02",
      "dateReceived": "1997-03-07"
    },
    {
      "kNumber": "K970009",
      "deviceName": "LYFO(TM) DIFFERENTIAL DISK-BACITRACIN",
      "applicant": "Microbiologics, Inc.",
      "company": "Microbiologics, Inc.",
      "decisionDate": "1997-02-06",
      "dateReceived": "1997-01-02"
    },
    {
      "kNumber": "K962966",
      "deviceName": "IDS RAPID CB PLUS SYSTEM",
      "applicant": "Innovative Diagnostic Systems, Inc.",
      "company": "Innovative Diagnostic Systems, Inc.",
      "decisionDate": "1996-10-08",
      "dateReceived": "1996-07-30"
    },
    {
      "kNumber": "K961191",
      "deviceName": "COLISCREEN",
      "applicant": "Hardy Diagnostics",
      "company": "Hardy Diagnostics",
      "decisionDate": "1996-06-17",
      "dateReceived": "1996-03-26"
    },
    {
      "kNumber": "K960996",
      "deviceName": "M. CAT BUTYRATE DISK",
      "applicant": "Hardy Diagnostics",
      "company": "Hardy Diagnostics",
      "decisionDate": "1996-04-18",
      "dateReceived": "1996-03-12"
    },
    {
      "kNumber": "K955826",
      "deviceName": "GIBSON ID-M. CAT.",
      "applicant": "Gibson Laboratories, Inc.",
      "company": "Gibson Laboratories LLC",
      "decisionDate": "1996-02-29",
      "dateReceived": "1995-12-26"
    },
    {
      "kNumber": "K954783",
      "deviceName": "DRYSLIDE CARTARRHALIS",
      "applicant": "Difco Laboratories, Inc.",
      "company": "Difco Laboratories, Inc.",
      "decisionDate": "1996-02-06",
      "dateReceived": "1995-10-17"
    }
  ],
  "topApplicants": [
    {
      "name": "Remel Co.",
      "count": 46
    },
    {
      "name": "Difco Laboratories, Inc.",
      "count": 34
    },
    {
      "name": "Dms Laboratories",
      "count": 13
    },
    {
      "name": "Austin Biological Laboratories",
      "count": 12
    },
    {
      "name": "E-Y Laboratories, Inc.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Remel, Inc.",
      "count": 49,
      "spellings": 2
    },
    {
      "name": "Difco Laboratories, Inc.",
      "count": 34,
      "spellings": 1
    },
    {
      "name": "Dms Laboratories",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Austin Biological Laboratories",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "E-Y Laboratories, Inc.",
      "count": 11,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JTO (Discs, Strips And Reagents, Microorganism Differentiation): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3AJTO"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJTO"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJTO"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJTO"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJTO"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJTO"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJTO"
    }
  ],
  "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": "2026-08-11T13:51:45.727Z"
}