{ "code": "DJG", "deviceName": "Enzyme Immunoassay, Opiates", "deviceClass": "II", "regulationNumber": "862.3650", "panel": "Clinical Toxicology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 215, "last12Months": 5 }, "adverseEvents": { "total": 4, "last12Months": 1 }, "reviewDays": { "median": 88, "sampleSize": 215 }, "recalls": { "total": 13, "recent": [ { "resNumber": "Z-0733-2026", "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-0734-2026", "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-2073-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Ortho-Clinical Diagnostics, Inc.", "firmAsPublished": "Ortho-Clinical Diagnostics, Inc.", "reason": "Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.", "initiated": "2025-06-12" }, { "resNumber": "Z-1743-2020", "status": "Terminated", "recallClass": "Class II", "firm": "Carolina Liquid Chemistries", "firmAsPublished": "Carolina Liquid Chemistries Corp", "reason": "Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers that products are labeled for \"Forensic Use Only\" and are not FDA Cleared and not to be used for clinical purposes", "initiated": "2020-01-20" }, { "resNumber": "Z-1751-2020", "status": "Terminated", "recallClass": "Class II", "firm": "Beckman Coulter, Inc.", "firmAsPublished": "Beckman Coulter Inc.", "reason": "Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.", "initiated": "2019-09-04" } ] }, "recentClearances": [ { "kNumber": "K252684", "deviceName": "Labcorp Fentanyl Urine Visual Test", "applicant": "Medtox Diagnostics, Inc.", "company": "Medtox Diagnostics Inc", "decisionDate": "2026-01-29", "dateReceived": "2025-08-25" }, { "kNumber": "K250741", "deviceName": "Evidence MultiSTAT DOA Urine MultiPlex", "applicant": "Randox Laboratories Limited", "company": "Randox Laboratories, Limited", "decisionDate": "2026-01-23", "dateReceived": "2025-03-11" }, { "kNumber": "K253082", "deviceName": "LZI Buprenorphine II Enzyme Immunoassay", "applicant": "Lin-Zhi International, Inc.", "company": "Lin-Zhi International Inc", "decisionDate": "2026-01-16", "dateReceived": "2025-09-23" }, { "kNumber": "K252520", "deviceName": "SEFRIA™ Hydrocodone Oral Fluid", "applicant": "Immunalysis Corporation", "company": "Immunalysis Corporation", "decisionDate": "2025-09-11", "dateReceived": "2025-08-11" }, { "kNumber": "K251972", "deviceName": "Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)", "applicant": "Healgen Scientific,, LLC", "company": "Healgen Scientific Llc", "decisionDate": "2025-08-15", "dateReceived": "2025-06-26" }, { "kNumber": "K251634", "deviceName": "LZI Fentanyl III Enzyme Immunoassay", "applicant": "Lin-Zhi International, Inc.", "company": "Lin-Zhi International Inc", "decisionDate": "2025-06-18", "dateReceived": "2025-05-29" }, { "kNumber": "K240124", "deviceName": "BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader", "applicant": "Vivachek Biotech (Hangzhou) Co., Ltd.", "company": "Vivachek Biotech (Hangzhou) Co., Ltd.", "decisionDate": "2024-06-14", "dateReceived": "2024-01-16" }, { "kNumber": "K240698", "deviceName": "Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard", "applicant": "Guangzhou Decheng Biotechnology Co., Ltd.", "company": "Guangzhou Decheng Biotechnology Co., Ltd.", "decisionDate": "2024-05-10", "dateReceived": "2024-03-14" }, { "kNumber": "K231904", "deviceName": "Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard", "applicant": "Co-Innovation Biotech Co., Ltd.", "company": "Co-Innovation Biotech Co., Ltd.", "decisionDate": "2024-03-08", "dateReceived": "2023-06-28" }, { "kNumber": "K232228", "deviceName": "Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card", "applicant": "Shanghai Accurature Diagnostics Co., Ltd.", "company": "Shanghai Accurature Diagnostics Co., Ltd.", "decisionDate": "2024-02-23", "dateReceived": "2023-07-27" } ], "topApplicants": [ { "name": "Lin-Zhi International, Inc.", "count": 16 }, { "name": "Immunalysis Corporation", "count": 11 }, { "name": "Guangzhou Wondfo Biotech Co., Ltd.", "count": 8 }, { "name": "Syva Co.", "count": 8 }, { "name": "Medtox Diagnostics, Inc.", "count": 7 } ], "topCompanies": [ { "name": "Lin-Zhi International Inc", "count": 16, "spellings": 1 }, { "name": "Microgenics Corporation", "count": 13, "spellings": 2 }, { "name": "Immunalysis Corporation", "count": 11, "spellings": 1 }, { "name": "Guangzhou Wondfo Biotech Co., Ltd.", "count": 8, "spellings": 1 }, { "name": "Syva Co.", "count": 8, "spellings": 1 } ], "newEntrants": [], "baseline": { "months": [ { "month": "2024-02-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "DJG (Enzyme Immunoassay, Opiates) has two findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0733-2026, Z-0734-2026). The code is crowded, scoring 63 of 100 — 80 companies hold a clearance here and 5 arrived in the last 12 months (DJG:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-0733-2026", "Z-0734-2026" ], "severity": 75 }, { "kind": "crowding", "detail": "the code is crowded, scoring 63 of 100 — 80 companies hold a clearance here and 5 arrived in the last 12 months", "recordIds": [ "DJG: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%3ADJG" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADJG" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADJG" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADJG" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADJG" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADJG" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADJG" } ], "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": "2026-08-11T13:51:45.675Z" }