Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Clinical Toxicology — Predicate Candidate Screening

3,040 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.

74 daysmedian FDA review time
240 days90th percentile
2,000clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261364Atellica CH Acetaminophen 2 (ACTM)Siemens Healthcare Diagnostics, Inc.2026-07-24880
K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Assure Tech., LLC2026-07-17350
K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug UriVivachek Biotech (Hangzhou) Co., Ltd.2026-05-22350
K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip MGuangzhou Wondfo Biotech Co., Ltd.2026-04-281090
K253705Healgen® Accurate Oral Fluid Drug TestHealgen Scientific,, LLC2026-03-161120
K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CuWEBEST Biotech,, LLC2026-03-09340
K252523Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® AccHealgen Scientific,, LLC2026-02-121850
K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.2026-01-291570
K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited2026-01-233180
K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.2026-01-161150
K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen AccuratHealgen Scientific,, LLC2025-12-23360
K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation2025-11-261800
K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup MulGuangzhou Wondfo Biotech Co., Ltd.2025-11-18970
K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home TesAdvin Biotech, Inc.2025-10-09300
K250609Sober Self-TestSober Ip, LLC2025-09-151990
K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Vivachek Biotech (Hangzhou) Co., Ltd.2025-09-12300
K243926Vivatmo pro-SBosch Healthcare Solutions GmbH2025-09-112650
K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation2025-09-11310
K252118CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Hangzhou Clongene Biotech Co., Ltd.2025-08-27510
K252259AssureTech Quick Cup Tests; AssureTech Multi-drug Urine TestAssure Tech., LLC2025-08-15250
K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)TeHealgen Scientific,, LLC2025-08-15500
K243462Diazyme Colorimetric Lithium AssayDiazyme Laboratories, Inc.2025-08-012660
K243500ARCHITECT iGentamicinAbbott Laboratories2025-07-092390
K251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.2025-06-18200
K250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Anhui Deepblue Medical Technological Co., Ltd.2025-04-15290
K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Hangzhou AllTest Biotech Co., Ltd.2025-04-04240
K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd.2025-03-184110
K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Hangzhou AllTest Biotech Co., Ltd.2025-02-27590
K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Guangzhou Decheng Biotechnology Co., Ltd.2025-02-20410
K243996AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssuAssure Tech., LLC2025-02-07430
K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine TeGuangzhou Decheng Biotechnology Co., Ltd.2025-02-061750
K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen AcHealgen Scientific,, LLC2024-12-17490
K243498Alinity c Benzodiazepines Reagent KitMicrogenics Corporation2024-12-11290
K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETEterbio, Inc.2024-11-20540
K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl TestHangzhou Clongene Biotech Co., Ltd.2024-11-08520
K240670DRI Ecstasy Plus AssayMicrogenics Corporation2024-10-302330
K241869BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIAVivachek Biotech (Hangzhou) Co., Ltd.2024-10-04990
K242498Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test PanAicheck Biotech, Inc.2024-10-01400
K242540AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug RapiHangzhou AllTest Biotech Co., Ltd.2024-09-27320
K242077PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug TeAicheck Biotech, Inc.2024-08-14290
K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test PaneQingdao Hightop Biotech Co., Ltd.2024-08-14400
K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ FenGuangzhou Wondfo Biotech Co., Ltd.2024-07-16290
K241428AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug RapidHangzhou AllTest Biotech Co., Ltd.2024-06-17280
K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA ReaVivachek Biotech (Hangzhou) Co., Ltd.2024-06-141500
K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl Co-Innovation Biotech Co., Ltd.2024-05-22300
K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); HealHealgen Scientific,, LLC2024-05-13350
K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-DrugGuangzhou Decheng Biotechnology Co., Ltd.2024-05-10570
K240686Healgen Accurate Urine Drug Screen Dip Card; Healgen AccuratHealgen Scientific,, LLC2024-04-12310
K240654SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine TeSafecare Biotech (Hangzhou) Co., Ltd.2024-04-10340
K240295InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Instanosis, Inc.2024-03-28560

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda