{
  "code": "JWY",
  "deviceName": "Manual Antimicrobial Susceptibility Test Systems",
  "deviceClass": "II",
  "regulationNumber": "866.1640",
  "panel": "Microbiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 441,
    "last12Months": 7
  },
  "adverseEvents": {
    "total": 4,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 69,
    "sampleSize": 441
  },
  "recalls": {
    "total": 78,
    "recent": [
      {
        "resNumber": "Z-1947-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel, Inc",
        "reason": "Product may have an off color affecting perfomance",
        "initiated": "2025-05-01"
      },
      {
        "resNumber": "Z-0817-2023",
        "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-0818-2023",
        "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-0819-2023",
        "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-0820-2023",
        "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": "K260447",
      "deviceName": "ETEST Gepotidacin (GEP) (0.016-256 µg/mL)",
      "applicant": "bioMérieux SA",
      "company": "bioMerieux, Inc.",
      "decisionDate": "2026-04-21",
      "dateReceived": "2026-02-11"
    },
    {
      "kNumber": "K260696",
      "deviceName": "MTS Gepotidacin 0.016-256 µg/mL",
      "applicant": "Liofilchem s.r.l.",
      "company": "Liofilchem s.r.l.",
      "decisionDate": "2026-04-17",
      "dateReceived": "2026-03-03"
    },
    {
      "kNumber": "K252114",
      "deviceName": "MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL",
      "applicant": "Liofilchem s.r.l.",
      "company": "Liofilchem s.r.l.",
      "decisionDate": "2025-10-02",
      "dateReceived": "2025-07-07"
    },
    {
      "kNumber": "K252062",
      "deviceName": "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL",
      "applicant": "Thermo Fisher Scientific",
      "company": "Thermo Fisher Scientific",
      "decisionDate": "2025-09-25",
      "dateReceived": "2025-07-01"
    },
    {
      "kNumber": "K250575",
      "deviceName": "The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL",
      "applicant": "Thermo Fisher Scientific",
      "company": "Thermo Fisher Scientific",
      "decisionDate": "2025-09-05",
      "dateReceived": "2025-02-26"
    },
    {
      "kNumber": "K252014",
      "deviceName": "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL",
      "applicant": "Thermo Fisher Scientific",
      "company": "Thermo Fisher Scientific",
      "decisionDate": "2025-08-28",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K251580",
      "deviceName": "MTS Sulbactam-Durlobactam  0.004/4 - 64/4 µg/mL (SUD)",
      "applicant": "Liofilchem s.r.l.",
      "company": "Liofilchem s.r.l.",
      "decisionDate": "2025-08-20",
      "dateReceived": "2025-05-23"
    },
    {
      "kNumber": "K250990",
      "deviceName": "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL",
      "applicant": "Thermo Fisher Scientific",
      "company": "Thermo Fisher Scientific",
      "decisionDate": "2025-06-30",
      "dateReceived": "2025-03-31"
    },
    {
      "kNumber": "K242843",
      "deviceName": "The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.",
      "applicant": "Thermo Fisher Scientific",
      "company": "Thermo Fisher Scientific",
      "decisionDate": "2025-06-20",
      "dateReceived": "2024-09-20"
    },
    {
      "kNumber": "K250856",
      "deviceName": "ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)",
      "applicant": "Biomérieux",
      "company": "bioMerieux, Inc.",
      "decisionDate": "2025-06-12",
      "dateReceived": "2025-03-21"
    }
  ],
  "topApplicants": [
    {
      "name": "Ab Biodisk",
      "count": 61
    },
    {
      "name": "Thermo Fisher Scientific",
      "count": 47
    },
    {
      "name": "Trek Diagnostic Systems, Inc.",
      "count": 44
    },
    {
      "name": "Pasco Laboratories, Inc.",
      "count": 39
    },
    {
      "name": "Liofilchem s.r.l.",
      "count": 35
    }
  ],
  "topCompanies": [
    {
      "name": "Ab Biodisk",
      "count": 61,
      "spellings": 1
    },
    {
      "name": "Trek Diagnostic Systems",
      "count": 51,
      "spellings": 3
    },
    {
      "name": "Thermo Fisher Scientific",
      "count": 47,
      "spellings": 1
    },
    {
      "name": "Pasco Laboratories, Inc.",
      "count": 39,
      "spellings": 1
    },
    {
      "name": "Liofilchem s.r.l.",
      "count": 35,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JWY (Manual Antimicrobial Susceptibility Test Systems): 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%3AJWY"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJWY"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJWY"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJWY"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJWY"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJWY"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJWY"
    }
  ],
  "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": "2026-08-11T13:51:45.728Z"
}