{
  "code": "CHH",
  "deviceName": "Enzymatic Esterase--Oxidase, Cholesterol",
  "deviceClass": "I",
  "regulationNumber": "862.1175",
  "panel": "Clinical Chemistry",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 230,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 30,
    "last12Months": 12
  },
  "reviewDays": {
    "median": 50,
    "sampleSize": 230
  },
  "recalls": {
    "total": 23,
    "recent": [
      {
        "resNumber": "Z-2085-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "DFI Co., Ltd.",
        "firmAsPublished": "DFI Co., Ltd.",
        "reason": "The devices were distributed without required FDA premarket clearance or approval.",
        "initiated": "2026-04-02"
      },
      {
        "resNumber": "Z-1424-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Randox Laboratories, Limited",
        "firmAsPublished": "Randox Laboratories Ltd.",
        "reason": "Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.",
        "initiated": "2022-06-22"
      },
      {
        "resNumber": "Z-0399-2022",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Beckman Coulter, Inc.",
        "firmAsPublished": "Beckman Coulter Inc.",
        "reason": "Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.",
        "initiated": "2021-11-10"
      },
      {
        "resNumber": "Z-0328-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Randox Laboratories, Limited",
        "firmAsPublished": "Randox Laboratories Ltd.",
        "reason": "When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range",
        "initiated": "2021-11-01"
      },
      {
        "resNumber": "Z-2157-2019",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Polymer Technology Systems, Inc.",
        "firmAsPublished": "Polymer Technology Systems, Inc.",
        "reason": "The MEMo chips provided with lot P901 may be mislabeled,  the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901",
        "initiated": "2019-06-07"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251091",
      "deviceName": "Lipids",
      "applicant": "Truvian Health",
      "company": "Truvian Health",
      "decisionDate": "2025-12-30",
      "dateReceived": "2025-04-10"
    },
    {
      "kNumber": "K232404",
      "deviceName": "CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES",
      "applicant": "Medicon Hellas S.A",
      "company": "Medicon Hellas S.A",
      "decisionDate": "2024-08-09",
      "dateReceived": "2023-08-10"
    },
    {
      "kNumber": "K203597",
      "deviceName": "Cholesterol2",
      "applicant": "Abbott Ireland Diagnostics Division",
      "company": "Abbott Ireland Diagnostics Division",
      "decisionDate": "2022-06-30",
      "dateReceived": "2020-12-09"
    },
    {
      "kNumber": "K190490",
      "deviceName": "VITROS XT Chemistry Products TRIG-CHOL Slides",
      "applicant": "Ortho-Clinical Diagnostics, Inc.",
      "company": "Ortho-Clinical Diagnostics, Inc.",
      "decisionDate": "2019-03-27",
      "dateReceived": "2019-02-28"
    },
    {
      "kNumber": "K181373",
      "deviceName": "Extended Lipid Panel Assay",
      "applicant": "Laboratory Corporation of America Holdings",
      "company": "Laboratory Corporation of America Holdings",
      "decisionDate": "2018-10-18",
      "dateReceived": "2018-05-24"
    },
    {
      "kNumber": "K180504",
      "deviceName": "Mission Lipid Panel Monitoring System",
      "applicant": "ACON Laboratories, Inc.",
      "company": "Acon Laboratories, Inc.",
      "decisionDate": "2018-03-28",
      "dateReceived": "2018-02-26"
    },
    {
      "kNumber": "K163406",
      "deviceName": "Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System",
      "applicant": "ACON Laboratories, Inc.",
      "company": "Acon Laboratories, Inc.",
      "decisionDate": "2017-07-11",
      "dateReceived": "2016-12-05"
    },
    {
      "kNumber": "K151545",
      "deviceName": "CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System",
      "applicant": "Polymer Technology Systems, Inc.",
      "company": "Polymer Technology Systems, Inc.",
      "decisionDate": "2016-12-22",
      "dateReceived": "2015-06-09"
    },
    {
      "kNumber": "K150654",
      "deviceName": "Cholesterol",
      "applicant": "Randox Laboratories, Ltd.",
      "company": "Randox Laboratories, Limited",
      "decisionDate": "2015-09-29",
      "dateReceived": "2015-03-13"
    },
    {
      "kNumber": "K132031",
      "deviceName": "AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL",
      "applicant": "Axis-Shield Poc AS",
      "company": "Axis-Shield Poc AS",
      "decisionDate": "2014-03-21",
      "dateReceived": "2013-07-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Cholestech Corp.",
      "count": 10
    },
    {
      "name": "Em Diagnostic Systems, Inc.",
      "count": 10
    },
    {
      "name": "Beckman Instruments, Inc.",
      "count": 7
    },
    {
      "name": "Boehringer Mannheim Corp.",
      "count": 7
    },
    {
      "name": "Polymer Technology Systems, Inc.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Cholestech Corp.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Em Diagnostic Systems, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Beckman Instruments, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Boehringer Mannheim Corp.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Polymer Technology Systems, Inc.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Truvian Health",
      "since": "2025-12-30",
      "kNumber": "K251091"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 3,
        "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": "2025-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-02-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "CHH (Enzymatic Esterase--Oxidase, Cholesterol) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2085-2026). 1 first-time filer in the last 12 months, Truvian Health (K251091). The code is crowded, scoring 67 of 100 — 128 companies hold a clearance here and 1 arrived in the last 12 months (CHH:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2085-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Truvian Health",
        "recordIds": [
          "K251091"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 67 of 100 — 128 companies hold a clearance here and 1 arrived in the last 12 months",
        "recordIds": [
          "CHH:crowding"
        ],
        "severity": 20
      }
    ],
    "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%3ACHH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACHH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACHH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACHH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACHH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACHH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACHH"
    }
  ],
  "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": "2026-08-11T13:51:45.672Z"
}