{ "code": "DIF", "deviceName": "Drug Mixture Control Materials", "deviceClass": "I", "regulationNumber": "862.3280", "panel": "Clinical Toxicology", "definition": null, "submissionTypeId": "4", "submissionType": "510(k)", "clearances": { "total": 202, "last12Months": 0 }, "adverseEvents": { "total": 0, "last12Months": 0 }, "reviewDays": { "median": 37, "sampleSize": 202 }, "recalls": { "total": 10, "recent": [ { "resNumber": "Z-0404-2022", "status": "Terminated", "recallClass": "Class II", "firm": "MEDLINE INDUSTRIES, LP - Northfield", "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield", "reason": "Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.", "initiated": "2021-11-30" }, { "resNumber": "Z-1552-2020", "status": "Terminated", "recallClass": "Class II", "firm": "QUIDEL CARDIOVASCULAR INC", "firmAsPublished": "QUIDEL CARDIOVASCULAR INC", "reason": "Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.", "initiated": "2019-04-09" }, { "resNumber": "Z-0911-2018", "status": "Terminated", "recallClass": "Class II", "firm": "Ortho-Clinical Diagnostics, Inc.", "firmAsPublished": "Ortho-Clinical Diagnostics", "reason": "This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.", "initiated": "2017-09-22" }, { "resNumber": "Z-0912-2018", "status": "Terminated", "recallClass": "Class II", "firm": "Ortho-Clinical Diagnostics, Inc.", "firmAsPublished": "Ortho-Clinical Diagnostics", "reason": "This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.", "initiated": "2017-09-22" }, { "resNumber": "Z-0913-2018", "status": "Terminated", "recallClass": "Class II", "firm": "Ortho-Clinical Diagnostics, Inc.", "firmAsPublished": "Ortho-Clinical Diagnostics", "reason": "This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.", "initiated": "2017-09-22" } ] }, "recentClearances": [ { "kNumber": "K153474", "deviceName": "Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series", "applicant": "Biochemical Diagnostics, Inc.", "company": "Biochemical Diagnostics Inc", "decisionDate": "2016-02-23", "dateReceived": "2015-12-02" }, { "kNumber": "K132688", "deviceName": "SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ", "applicant": "Biochemical Diagnostics, Inc.", "company": "Biochemical Diagnostics Inc", "decisionDate": "2013-12-16", "dateReceived": "2013-08-28" }, { "kNumber": "K132174", "deviceName": "MULTICHEM WBT", "applicant": "Techno-Path Manufacturing , Ltd.", "company": "TECHNO-PATH MANUFACTURING LTD.", "decisionDate": "2013-09-20", "dateReceived": "2013-07-15" }, { "kNumber": "K121122", "deviceName": "DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL", "applicant": "Biochemical Diagnostic, Inc.", "company": "Biochemical Diagnostic, Inc.", "decisionDate": "2012-07-03", "dateReceived": "2012-04-13" }, { "kNumber": "K121143", "deviceName": "LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)", "applicant": "Bio-Rad Laboratories", "company": "Bio-Rad Laboratories, Inc.", "decisionDate": "2012-05-18", "dateReceived": "2012-04-16" }, { "kNumber": "K120504", "deviceName": "LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK", "applicant": "Bio-Rad Laboratories, Inc.", "company": "Bio-Rad Laboratories, Inc.", "decisionDate": "2012-03-27", "dateReceived": "2012-02-21" }, { "kNumber": "K103656", "deviceName": "THERMO SCIENTIFIC MAS R DOA TOTAL", "applicant": "Microgenics Corporation", "company": "Microgenics Corporation", "decisionDate": "2011-03-24", "dateReceived": "2010-12-15" }, { "kNumber": "K093577", "deviceName": "LIQUICHEK OPIATE CONTROL", "applicant": "Bio-Rad Laboratories", "company": "Bio-Rad Laboratories, Inc.", "decisionDate": "2010-03-12", "dateReceived": "2009-11-18" }, { "kNumber": "K080085", "deviceName": "MAS TOX CONTROL", "applicant": "Thermo Fisher Scientific", "company": "Thermo Fisher Scientific", "decisionDate": "2008-04-30", "dateReceived": "2008-01-11" }, { "kNumber": "K080183", "deviceName": "CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500", "applicant": "Roche Diagnostics Corp.", "company": "Roche Diagnostics Corporation", "decisionDate": "2008-03-25", "dateReceived": "2008-01-25" } ], "topApplicants": [ { "name": "Bio-Rad", "count": 31 }, { "name": "Roche Diagnostic Systems, Inc.", "count": 14 }, { "name": "Medical Analysis Systems, Inc.", "count": 13 }, { "name": "Syva Co.", "count": 13 }, { "name": "Utak Laboratories, Inc.", "count": 13 } ], "topCompanies": [ { "name": "Bio-Rad", "count": 31, "spellings": 1 }, { "name": "Roche Diagnostic Systems, Inc.", "count": 14, "spellings": 1 }, { "name": "Medical Analysis Systems, Inc.", "count": 13, "spellings": 1 }, { "name": "Syva Co.", "count": 13, "spellings": 1 }, { "name": "Utak Laboratories Inc", "count": 13, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [], "sufficientMonths": 0, "method": null }, "signal": { "summary": "DIF (Drug Mixture Control Materials): 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%3ADIF" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADIF" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADIF" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADIF" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADIF" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADIF" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADIF" } ], "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" }