{ "code": "LCP", "deviceName": "Assay, Glycosylated Hemoglobin", "deviceClass": "II", "regulationNumber": "864.7470", "panel": "Hematology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 249, "last12Months": 0 }, "adverseEvents": { "total": 125, "last12Months": 47 }, "reviewDays": { "median": 100, "sampleSize": 249 }, "recalls": { "total": 103, "recent": [ { "resNumber": "Z-0732-2026", "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-1830-2025", "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-0223-2025", "status": "Completed", "recallClass": "Class II", "firm": "Polymer Technology Systems, Inc.", "firmAsPublished": "Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.", "reason": "The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.", "initiated": "2024-09-18" }, { "resNumber": "Z-2736-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Abbott Diagnostics Technologies AS", "firmAsPublished": "Abbott Diagnostics Technologies AS", "reason": "Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.", "initiated": "2024-06-17" }, { "resNumber": "Z-1304-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Siemens Healthcare Diagnostics, Inc.", "firmAsPublished": "Siemens Healthcare Diagnostics, Inc.", "reason": "The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.", "initiated": "2024-02-07" } ] }, "recentClearances": [ { "kNumber": "K221326", "deviceName": "Nova Allegro HbA1c Assay, Nova Allegro Analyzer", "applicant": "Nova Biomedical Corporation", "company": "Nova Biomedical Corporation", "decisionDate": "2024-11-22", "dateReceived": "2022-05-06" }, { "kNumber": "K231465", "deviceName": "Q-Pad Test System", "applicant": "Qurasense", "company": "QURASENSE, INC.", "decisionDate": "2023-12-06", "dateReceived": "2023-05-19" }, { "kNumber": "K214117", "deviceName": "Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer", "applicant": "Abbott Diagnostics Technologies AS", "company": "Abbott Diagnostics Technologies AS", "decisionDate": "2023-09-27", "dateReceived": "2021-12-30" }, { "kNumber": "K192987", "deviceName": "Aina HbA1c Monitoring System 2", "applicant": "Jana Care, Inc.", "company": "Jana Care, Inc.", "decisionDate": "2020-03-26", "dateReceived": "2019-10-25" }, { "kNumber": "K192369", "deviceName": "PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit", "applicant": "Ixensor Co, Ltd.", "company": "Ixensor Company , Ltd.", "decisionDate": "2019-10-29", "dateReceived": "2019-08-30" }, { "kNumber": "K183230", "deviceName": "OneDraw A1C Test System", "applicant": "Drawbridge Health, Inc.", "company": "Drawbridge Health, Inc.", "decisionDate": "2019-08-15", "dateReceived": "2018-11-20" }, { "kNumber": "K181915", "deviceName": "PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit", "applicant": "Ixensor Co, Ltd.", "company": "Ixensor Company , Ltd.", "decisionDate": "2019-04-12", "dateReceived": "2018-07-17" }, { "kNumber": "K180509", "deviceName": "Quo-Test A1c System", "applicant": "Ekf-Diagnostic GmbH", "company": "Ekf Diagnostic GmbH", "decisionDate": "2019-02-16", "dateReceived": "2018-02-27" }, { "kNumber": "K173127", "deviceName": "skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)", "applicant": "Skyla Corporation H.S.P.B", "company": "Skyla Corporation H.S.P.B", "decisionDate": "2018-09-25", "dateReceived": "2017-09-29" }, { "kNumber": "K170623", "deviceName": "ACE Hemoglobin A1c (HbA1c) Reagent", "applicant": "Alfa Wassermann Diagnostic Technologies, LLC", "company": "Alfa Wassermann Diagnostic Technologies, Inc.", "decisionDate": "2018-02-27", "dateReceived": "2017-03-01" } ], "topApplicants": [ { "name": "Helena Laboratories", "count": 19 }, { "name": "Bio-Rad", "count": 15 }, { "name": "Bio-Rad Laboratories, Inc.", "count": 8 }, { "name": "Abbott Laboratories", "count": 7 }, { "name": "Isolab, Inc.", "count": 7 } ], "topCompanies": [ { "name": "Helena Laboratories, Corp.", "count": 19, "spellings": 1 }, { "name": "Bio-Rad", "count": 15, "spellings": 1 }, { "name": "Primus Corporation dba Trinity Biotech", "count": 10, "spellings": 3 }, { "name": "Bio-Rad Laboratories, Inc.", "count": 8, "spellings": 1 }, { "name": "Abbott Laboratories, Inc.", "count": 7, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 5, "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": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1, "expectedLow": 0, "expectedHigh": 5.8039350610213525, "isSufficient": true }, { "month": "2025-03-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-04-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 2, "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": "2025-10-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 31, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 9, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 1, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "LCP (Assay, Glycosylated Hemoglobin) has one finding. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0732-2026).", "severity": 75, "factors": [ { "kind": "recall", "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-0732-2026" ], "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%3ALCP" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALCP" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALCP" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALCP" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALCP" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALCP" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALCP" } ], "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": "2026-08-11T13:51:45.737Z" }