{
  "code": "JSG",
  "deviceName": "Culture Media, Non-Selective And Non-Differential",
  "deviceClass": "I",
  "regulationNumber": "866.2300",
  "panel": "Microbiology",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 209,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 427,
    "last12Months": 97
  },
  "reviewDays": {
    "median": 25,
    "sampleSize": 209
  },
  "recalls": {
    "total": 29,
    "recent": [
      {
        "resNumber": "Z-1828-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
        "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office",
        "reason": "transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.",
        "initiated": "2025-04-24"
      },
      {
        "resNumber": "Z-1417-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Vectornate USA Inc",
        "firmAsPublished": "Vectornate USA Inc",
        "reason": "Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.",
        "initiated": "2021-02-16"
      },
      {
        "resNumber": "Z-1377-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel Inc",
        "reason": "Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing.  Expiration date is shortened from 7 months to 56 days.",
        "initiated": "2019-04-17"
      },
      {
        "resNumber": "Z-1378-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel Inc",
        "reason": "Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing.  Expiration date is shortened from 7 months to 56 days.",
        "initiated": "2019-04-17"
      },
      {
        "resNumber": "Z-1379-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Remel, Inc.",
        "firmAsPublished": "Remel Inc",
        "reason": "Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing.  Expiration date is shortened from 7 months to 56 days.",
        "initiated": "2019-04-17"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K882495",
      "deviceName": "THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007",
      "applicant": "Lakewood Biochemical Co., Inc.",
      "company": "Lakewood Biochemical Co., Inc.",
      "decisionDate": "1988-07-01",
      "dateReceived": "1988-06-16"
    },
    {
      "kNumber": "K881564",
      "deviceName": "TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-11"
    },
    {
      "kNumber": "K881563",
      "deviceName": "TRYPTOSE PHOSPHATE BROTH",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-11"
    },
    {
      "kNumber": "K881562",
      "deviceName": "TRYPTOSE BLOOD AGAR BASE",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-11"
    },
    {
      "kNumber": "K881558",
      "deviceName": "TRYPTOSE AGAR",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-08"
    },
    {
      "kNumber": "K881557",
      "deviceName": "TRYPTONE",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-08"
    },
    {
      "kNumber": "K881554",
      "deviceName": "SKIM MILK DEHYDRATED",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-08"
    },
    {
      "kNumber": "K881550",
      "deviceName": "OF BASAL MEDIUM",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-08"
    },
    {
      "kNumber": "K881548",
      "deviceName": "MPH AGAR",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-08"
    },
    {
      "kNumber": "K881546",
      "deviceName": "MALT EXTRACT AGAR",
      "applicant": "Acumedia Manufacturers, Inc.",
      "company": "Acumedia Manufacturers, Inc.",
      "decisionDate": "1988-04-18",
      "dateReceived": "1988-04-08"
    }
  ],
  "topApplicants": [
    {
      "name": "Acumedia Manufacturers, Inc.",
      "count": 42
    },
    {
      "name": "Lakewood Biochemical Co., Inc.",
      "count": 28
    },
    {
      "name": "Otisville Biotech, Inc.",
      "count": 17
    },
    {
      "name": "Isle Media and Sterile Products, Inc.",
      "count": 15
    },
    {
      "name": "Hardy Media",
      "count": 13
    }
  ],
  "topCompanies": [
    {
      "name": "Acumedia Manufacturers, Inc.",
      "count": 42,
      "spellings": 1
    },
    {
      "name": "Lakewood Biochemical Co., Inc.",
      "count": 28,
      "spellings": 1
    },
    {
      "name": "Otisville Biotech, Inc.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Isle Media and Sterile Products, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Hardy Media Inc Dba Hardy Diag",
      "count": 13,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 158,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "JSG (Culture Media, Non-Selective And Non-Differential): 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%3AJSG"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJSG"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJSG"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJSG"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJSG"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJSG"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJSG"
    }
  ],
  "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": "2026-08-11T13:51:45.726Z"
}