Devices descending from K040316
52 later devices reach Cedia Buprenorphine Assay through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative… | Microgenics Corporation | 2017 | 0 | — |
| +1 | K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level… | Siemens Healthcare Diagnostics, Inc. | 2015 | 25 | — |
| +1 | K141406 | Immunalysis Buprenorphine Urine Enzyme Immunoassay, Immunalysis Buprenorphine Urine… | Immunalysis Corporation | 2014 | 0 | — |
| +1 | K081008 | Buprenorphine Enzyme Immunoassay, Calibrators and Controls for Beckman Coulter Synchron… | Lin-Zhi International, Inc. | 2008 | 2 | 2 |
| +1 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | 18 | — |
| +1 | K042990 | For Sure One Step Buprenorphine Test Strip | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | 1 | — |
| +2 | K221605 | Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics, Inc. | 2023 | 0 | — |
| +2 | K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine… | Immunalysis Corporation | 2017 | 23 | — |
| +2 | K122064 | Forsure One Step Buprenorphine Cup Test Device | Tianjin New Bay Bioresearch Co., Ltd. | 2013 | 0 | — |
| +2 | K090844 | Buprenorphine Enzyme Immunoassay with Norbuprenorphine Calibrators and Controls | Lin-Zhi International, Inc. | 2009 | 1 | — |
| +2 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | 17 | — |
| +3 | K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026 | 0 | — |
| +3 | K181159 | LZI Fentanyl Enzyme Immunoassay | Lin-Zhi International, Inc. | 2018 | 2 | — |
| +3 | K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018 | 19 | — |
| +3 | K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of… | Alfa Scientific Designs, Inc. | 2010 | 0 | — |
| +3 | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette… | Alfa Scientific Designs, Inc. | 2007 | 16 | — |
| +4 | K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 | Shenzhen Superbio Technology Co., Ltd. | 2022 | 17 | — |
| +4 | K201938 | LZI Fentanyl II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020 | 1 | — |
| +4 | K200197 | ARK Fentanyl II Assay | Ark Diagnostics, Inc. | 2020 | 0 | — |
| +4 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test… | Alfa Scientific Designs, Inc. | 2016 | 13 | — |
| +4 | K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette) | Alfa Scientific Designs, Inc. | 2013 | 0 | — |
| +5 | K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2025 | 0 | — |
| +5 | K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | 2 | — |
| +5 | K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024 | 1 | — |
| +5 | K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023 | 11 | — |
| +5 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW… | Alfa Scientific Designs, Inc. | 2018 | 12 | — |
| +6 | K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative… | Healgen Scientific,, LLC | 2025 | 0 | — |
| +6 | K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®… | Guangzhou Decheng Biotechnology Co., Ltd. | 2025 | 0 | — |
| +6 | K241869 | BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™… | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | 0 | — |
| +6 | K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard | Co-Innovation Biotech Co., Ltd. | 2024 | 0 | — |
| +6 | K233417 | AllTest Fentanyl Urine Test Cassette | Hangzhou AllTest Biotech Co., Ltd. | 2023 | 9 | — |
| +6 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug… | Hangzhou AllTest Biotech Co., Ltd. | 2019 | 9 | — |
| +6 | K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test… | Shanghai Venture Bio-Tech Co., Ltd. | 2018 | 0 | — |
| +6 | K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug… | Shanghai Venture Bio-Tech Co., Ltd. | 2018 | 0 | — |
| +7 | K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette | Hangzhou Clongene Biotech Co., Ltd. | 2024 | 0 | — |
| +7 | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®… | Qingdao Hightop Biotech Co., Ltd. | 2024 | 1 | — |
| +7 | K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test… | Guangzhou Wondfo Biotech Co., Ltd. | 2024 | 0 | — |
| +7 | K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl… | Healgen Scientific,, LLC | 2024 | 0 | — |
| +7 | K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette | Safecare Biotech (Hangzhou) Co., Ltd. | 2024 | 0 | — |
| +7 | K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) | Instanosis, Inc. | 2024 | 0 | — |
| +7 | K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test | Allsource Screening Solutions | 2024 | 0 | — |
| +7 | K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) | Assure Tech., LLC | 2024 | 0 | — |
| +7 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest… | Hangzhou AllTest Biotech Co., Ltd. | 2023 | 8 | — |
| +8 | K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025 | 4 | — |
| +8 | K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl… | Eterbio, Inc. | 2024 | 0 | — |
| +8 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2024 | 2 | — |
| +9 | K261409 | BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. | 2026 | 0 | — |
| +9 | K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup | WEBEST Biotech,, LLC | 2026 | 0 | — |
| +9 | K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup | Advin Biotech, Inc. | 2025 | 0 | — |
| +9 | K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2025 | 1 | — |
| +9 | K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel | Hangzhou AllTest Biotech Co., Ltd. | 2024 | 0 | — |
| +10 | K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup | Hangzhou Clongene Biotech Co., Ltd. | 2025 | 0 | — |