{ "code": "GGP", "deviceName": "Test, Qualitative And Quantitative Factor Deficiency", "deviceClass": "II", "regulationNumber": "864.7290", "panel": "Hematology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 190, "last12Months": 1 }, "adverseEvents": { "total": 3, "last12Months": 2 }, "reviewDays": { "median": 71, "sampleSize": 190 }, "recalls": { "total": 13, "recent": [ { "resNumber": "Z-1491-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Diagnostica Stago, Inc.", "firmAsPublished": "Diagnostica Stago, Inc.", "reason": "The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.", "initiated": "2026-02-04" }, { "resNumber": "Z-1227-2023", "status": "Open, Classified", "recallClass": "Class II", "firm": "Aniara Diagnostica LLC", "firmAsPublished": "Aniara Diagnostica LLC", "reason": "New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility", "initiated": "2023-02-01" }, { "resNumber": "Z-1699-2020", "status": "Terminated", "recallClass": "Class II", "firm": "Diagnostica Stago, Inc.", "firmAsPublished": "Diagnostica Stago, Inc.", "reason": "A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased", "initiated": "2020-03-04" }, { "resNumber": "Z-0106-2019", "status": "Terminated", "recallClass": "Class II", "firm": "Helena Laboratories, Corp.", "firmAsPublished": "Helena Laboratories, Inc.", "reason": "Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.", "initiated": "2017-04-04" }, { "resNumber": "Z-0736-2016", "status": "Terminated", "recallClass": "Class II", "firm": "Instrumentation Laboratory", "firmAsPublished": "Instrumentation Laboratory Co.", "reason": "This Lot is not meeting labeled on-board instrument stability claims of 5 days.", "initiated": "2015-12-18" } ] }, "recentClearances": [ { "kNumber": "K251440", "deviceName": "CRYOcheck Chromogenic Factor VIII", "applicant": "Precision Biologic, Inc.", "company": "Precision Biologic, Inc.", "decisionDate": "2025-08-25", "dateReceived": "2025-05-09" }, { "kNumber": "K230852", "deviceName": "HemosIL Chromogenic Factor IX", "applicant": "Instrumentation Laboratory Company", "company": "Instrumentation Laboratory", "decisionDate": "2023-12-13", "dateReceived": "2023-03-28" }, { "kNumber": "K220728", "deviceName": "vWF Ag", "applicant": "Siemens Healthcare Diagnostics Products GmbH", "company": "Siemens Healthcare Diagnostics Products GmbH", "decisionDate": "2023-06-02", "dateReceived": "2022-03-14" }, { "kNumber": "K214002", "deviceName": "CRYOcheck Chromogenic Factor IX", "applicant": "Precision Biologic, Inc.", "company": "Precision Biologic, Inc.", "decisionDate": "2022-12-23", "dateReceived": "2021-12-21" }, { "kNumber": "K223402", "deviceName": "HemosIL von Willebrand Factor Antigen", "applicant": "Instrumentation Laboratory CO", "company": "Instrumentation Laboratory", "decisionDate": "2022-12-09", "dateReceived": "2022-11-09" }, { "kNumber": "K200033", "deviceName": "HemosIL von Willebrand Factor Antigen", "applicant": "Instrumentation Laboratory CO", "company": "Instrumentation Laboratory", "decisionDate": "2020-08-19", "dateReceived": "2020-01-07" }, { "kNumber": "K193204", "deviceName": "Cryocheck Chromogenic Factor VIII", "applicant": "Precision Biologic", "company": "Precision Biologic, Inc.", "decisionDate": "2020-07-17", "dateReceived": "2019-11-20" }, { "kNumber": "K183440", "deviceName": "CRYOcheck FVIII Inhibitor Kit", "applicant": "Precision Biologic, Inc.", "company": "Precision Biologic, Inc.", "decisionDate": "2019-03-12", "dateReceived": "2018-12-12" }, { "kNumber": "K181525", "deviceName": "INNOVANCE Free PS Ag", "applicant": "Siemens Healthcare Diagnostics Products GmbH", "company": "Siemens Healthcare Diagnostics Products GmbH", "decisionDate": "2018-09-07", "dateReceived": "2018-06-11" }, { "kNumber": "K133005", "deviceName": "HEMOSIL VON WILLEBRAND ACTIVITY ASSAY", "applicant": "Instrumentation Laboratory CO", "company": "Instrumentation Laboratory", "decisionDate": "2014-03-13", "dateReceived": "2013-09-25" } ], "topApplicants": [ { "name": "Instrumentation Laboratory CO", "count": 27 }, { "name": "American Bioproducts Co.", "count": 22 }, { "name": "Helena Laboratories", "count": 17 }, { "name": "American Dade", "count": 9 }, { "name": "Biopool AB", "count": 9 } ], "topCompanies": [ { "name": "Instrumentation Laboratory", "count": 28, "spellings": 2 }, { "name": "American Bioproducts Co.", "count": 22, "spellings": 1 }, { "name": "Helena Laboratories, Corp.", "count": 17, "spellings": 1 }, { "name": "American Dade", "count": 9, "spellings": 1 }, { "name": "Biopool AB", "count": 9, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "GGP (Test, Qualitative And Quantitative Factor Deficiency) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1491-2026).", "severity": 75, "factors": [ { "kind": "recall", "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-1491-2026" ], "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%3AGGP" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGGP" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AGGP" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AGGP" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AGGP" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AGGP" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AGGP" } ], "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": "2026-08-11T13:51:45.703Z" }