{
  "code": "DHB",
  "deviceName": "System, Test, Radioallergosorbent (Rast) Immunological",
  "deviceClass": "II",
  "regulationNumber": "866.5750",
  "panel": "Immunology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 268,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 22,
    "last12Months": 7
  },
  "reviewDays": {
    "median": 75,
    "sampleSize": 268
  },
  "recalls": {
    "total": 27,
    "recent": [
      {
        "resNumber": "Z-0759-2026",
        "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-0760-2026",
        "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-0761-2026",
        "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-0762-2026",
        "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-0769-2026",
        "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"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261027",
      "deviceName": "NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, Peanut",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2026-07-24",
      "dateReceived": "2026-03-30"
    },
    {
      "kNumber": "K260591",
      "deviceName": "NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, Peanut",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2026-07-21",
      "dateReceived": "2026-02-23"
    },
    {
      "kNumber": "K260280",
      "deviceName": "NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2026-06-18",
      "dateReceived": "2026-01-29"
    },
    {
      "kNumber": "K260059",
      "deviceName": "NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2026-05-15",
      "dateReceived": "2026-01-08"
    },
    {
      "kNumber": "K252775",
      "deviceName": "NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk;  Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2026-01-16",
      "dateReceived": "2025-09-02"
    },
    {
      "kNumber": "K252493",
      "deviceName": "NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2025-12-23",
      "dateReceived": "2025-08-08"
    },
    {
      "kNumber": "K242531",
      "deviceName": "NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2025-04-23",
      "dateReceived": "2024-08-26"
    },
    {
      "kNumber": "K212181",
      "deviceName": "ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed",
      "applicant": "Phadia AB",
      "company": "Phadia Ab",
      "decisionDate": "2022-08-03",
      "dateReceived": "2021-07-13"
    },
    {
      "kNumber": "K220162",
      "deviceName": "Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria",
      "applicant": "Hycor Biomedical",
      "company": "Hycor Biomedical Inc",
      "decisionDate": "2022-02-18",
      "dateReceived": "2022-01-20"
    },
    {
      "kNumber": "K193613",
      "deviceName": "Allergen-Specific IgE Assay 12 Allergen Bundle",
      "applicant": "Hitachi Chemical Diagnostics, Inc.",
      "company": "Hitachi Chemical Diagnostics Inc",
      "decisionDate": "2021-10-18",
      "dateReceived": "2019-12-26"
    }
  ],
  "topApplicants": [
    {
      "name": "Pharmacia, Inc.",
      "count": 39
    },
    {
      "name": "Diagnostic Products Corp.",
      "count": 26
    },
    {
      "name": "Incstar Corp.",
      "count": 25
    },
    {
      "name": "Ventrex Laboratories, Inc.",
      "count": 18
    },
    {
      "name": "Phadia AB",
      "count": 16
    }
  ],
  "topCompanies": [
    {
      "name": "Pharmacia, Inc.",
      "count": 39,
      "spellings": 1
    },
    {
      "name": "Diagnostic Products Corp.",
      "count": 26,
      "spellings": 1
    },
    {
      "name": "Incstar Corp.",
      "count": 25,
      "spellings": 1
    },
    {
      "name": "Hycor Biomedical Inc",
      "count": 24,
      "spellings": 2
    },
    {
      "name": "Ventrex Laboratories, Inc.",
      "count": 18,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 3,
        "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": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "DHB (System, Test, Radioallergosorbent (Rast) Immunological) has one finding. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0759-2026, Z-0760-2026, Z-0761-2026, Z-0762-2026, Z-0769-2026).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0759-2026",
          "Z-0760-2026",
          "Z-0761-2026",
          "Z-0762-2026",
          "Z-0769-2026"
        ],
        "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%3ADHB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADHB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADHB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADHB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADHB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADHB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADHB"
    }
  ],
  "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": "2026-08-11T13:51:45.674Z"
}