{ "code": "JJX", "deviceName": "Single (Specified) Analyte Controls (Assayed And Unassayed)", "deviceClass": "I", "regulationNumber": "862.1660", "panel": "Clinical Chemistry", "definition": null, "submissionTypeId": "4", "submissionType": "510(k)", "clearances": { "total": 493, "last12Months": 0 }, "adverseEvents": { "total": 71, "last12Months": 14 }, "reviewDays": { "median": 43, "sampleSize": 493 }, "recalls": { "total": 42, "recent": [ { "resNumber": "Z-1854-2025", "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-1855-2025", "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-2019-2024", "status": "Open, Classified", "recallClass": "Class III", "firm": "Ortho-Clinical Diagnostics, Inc.", "firmAsPublished": "Ortho-Clinical Diagnostics, Inc.", "reason": "The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot.\nAs this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.", "initiated": "2024-05-08" }, { "resNumber": "Z-1312-2024", "status": "Open, Classified", "recallClass": "Class II", "firm": "Mckesson Medical-Surgical Inc. Corporate Office", "firmAsPublished": "Mckesson Medical-Surgical Inc. Corporate Office", "reason": "Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.", "initiated": "2024-01-09" }, { "resNumber": "Z-2225-2023", "status": "Open, Classified", "recallClass": "Class III", "firm": "Ortho-Clinical Diagnostics, Inc.", "firmAsPublished": "Ortho-Clinical Diagnostics, Inc.", "reason": "May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).", "initiated": "2023-05-18" } ] }, "recentClearances": [ { "kNumber": "K170678", "deviceName": "Beta-CrossLaps CalCheck 5", "applicant": "Roche Diagnostics", "company": "Roche Diagnostics Corporation", "decisionDate": "2017-04-04", "dateReceived": "2017-03-06" }, { "kNumber": "K162173", "deviceName": "Elecsys CYFRA 21-1 CalCheck 5", "applicant": "Roche Diagnostics", "company": "Roche Diagnostics Corporation", "decisionDate": "2017-01-12", "dateReceived": "2016-08-03" }, { "kNumber": "K162514", "deviceName": "Multichem A1c", "applicant": "Technopath Manufacturing", "company": "Technopath Manufacturing", "decisionDate": "2016-10-26", "dateReceived": "2016-09-08" }, { "kNumber": "K161874", "deviceName": "Audit MicroControls Linearity DROP LQ Blood Glucose", "applicant": "Aalto Scientific, Ltd.", "company": "Aalto Scientific, Ltd.", "decisionDate": "2016-08-10", "dateReceived": "2016-07-08" }, { "kNumber": "K161526", "deviceName": "LIAISON CMV IgM Serum Control Set", "applicant": "DiaSorin, Inc.", "company": "Diasorin Inc.", "decisionDate": "2016-06-30", "dateReceived": "2016-06-02" }, { "kNumber": "K161522", "deviceName": "LIAISON EBV IgM Serum Control Set", "applicant": "DiaSorin, Inc.", "company": "Diasorin Inc.", "decisionDate": "2016-06-30", "dateReceived": "2016-06-02" }, { "kNumber": "K161082", "deviceName": "IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers", "applicant": "Immunodiagnostic Systems , Ltd.", "company": "Immunodiagnostic Systems Limited", "decisionDate": "2016-05-17", "dateReceived": "2016-04-18" }, { "kNumber": "K152117", "deviceName": "Dropper hsCRP High Sensitivity CRP Control", "applicant": "Quantimetrix Corporation", "company": "Quantimetrix Corporation", "decisionDate": "2016-04-21", "dateReceived": "2015-07-30" }, { "kNumber": "K151742", "deviceName": "Contour Next Control Solution", "applicant": "Bayer Healthcare", "company": "Bayer Healthcare, LLC", "decisionDate": "2015-09-23", "dateReceived": "2015-06-29" }, { "kNumber": "K143687", "deviceName": "ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material", "applicant": "Siemens Healthcare Diagnostics, Inc.", "company": "Siemens Healthcare Diagnostics, Inc.", "decisionDate": "2015-07-17", "dateReceived": "2014-12-24" } ], "topApplicants": [ { "name": "Roche Diagnostics", "count": 35 }, { "name": "Siemens Healthcare Diagnostics, Inc.", "count": 27 }, { "name": "Boehringer Mannheim Corp.", "count": 24 }, { "name": "Bionostics, Inc.", "count": 22 }, { "name": "Roche Diagnostics Corp.", "count": 22 } ], "topCompanies": [ { "name": "Roche Diagnostics Corporation", "count": 60, "spellings": 4 }, { "name": "Siemens Healthcare Diagnostics, Inc.", "count": 34, "spellings": 2 }, { "name": "Boehringer Mannheim Corp.", "count": 24, "spellings": 1 }, { "name": "Bionostics, Inc.", "count": 22, "spellings": 1 }, { "name": "Bio-Rad", "count": 21, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2023-01-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 7, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "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": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-02-01", "observed": 1, "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": "2025-05-01", "observed": 2, "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": "2025-09-01", "observed": 8, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)): 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%3AJJX" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJX" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AJJX" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AJJX" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AJJX" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AJJX" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AJJX" } ], "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": "2026-08-11T13:51:45.721Z" }