Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DJG — Predicate Candidate Screening
215 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
278 days90th percentile
215clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual Test | Medtox Diagnostics, Inc. | 2026-01-29 | 157 | 0 |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026-01-23 | 318 | 0 |
| K253082 | LZI Buprenorphine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2026-01-16 | 115 | 0 |
| K252520 | SEFRIA™ Hydrocodone Oral Fluid | Immunalysis Corporation | 2025-09-11 | 31 | 0 |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Te | Healgen Scientific,, LLC | 2025-08-15 | 50 | 0 |
| K251634 | LZI Fentanyl III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2025-06-18 | 20 | 0 |
| K240124 | BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Rea | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-06-14 | 150 | 0 |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-05-10 | 57 | 0 |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test D | Co-Innovation Biotech Co., Ltd. | 2024-03-08 | 254 | 0 |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, A | Shanghai Accurature Diagnostics Co., Ltd. | 2024-02-23 | 211 | 0 |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Dr | Hangzhou Laihe Biotech Co., Ltd. | 2024-01-09 | 134 | 0 |
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® | Chemtron Biotech, Inc. | 2023-12-20 | 104 | 0 |
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Uri | Guangzhou Decheng Biotechnology Co., Ltd. | 2023-12-13 | 104 | 0 |
| K231752 | ARK Hydrocodone Assay | Ark Diagnostics, Inc. | 2023-11-09 | 147 | 0 |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | 2023-10-05 | 595 | 1 |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2023-10-05 | 492 | 0 |
| K231007 | CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation | 2023-09-27 | 173 | 0 |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2023-07-31 | 49 | 0 |
| K221605 | Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics, Inc. | 2023-07-25 | 418 | 0 |
| K230238 | BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch M | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2023-03-31 | 60 | 0 |
| K222955 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | 2023-02-06 | 132 | 0 |
| K220046 | Superbio Fentanyl Urine Detection Kit, Superbio Immunofluore | Shenzhen Superbio Technology Co., Ltd. | 2022-12-13 | 342 | 0 |
| K203527 | Immunalysis Tapentadol Urine HEIA | Lmmunalysis Corporation | 2022-05-09 | 523 | 0 |
| K203564 | SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021-12-22 | 380 | 0 |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA I | Assure Tech. (Hangzhou) Co, Ltd. | 2021-08-12 | 422 | 0 |
| K201326 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiat | Psychemedics Corporation | 2021-07-27 | 434 | 0 |
| K201494 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. | 2020-09-17 | 104 | 0 |
| K202007 | LZI Oxycodone III Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020-09-17 | 58 | 0 |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020-08-07 | 25 | 0 |
| K201223 | LZI Tramadol Enzyme Immunoassay | Lin-Zhi International, Inc. | 2020-06-04 | 29 | 0 |
| K200197 | ARK Fentanyl II Assay | Ark Diagnostics, Inc. | 2020-02-26 | 30 | 0 |
| K192943 | CEDIA Heroin Metabolite (6-AM) assay | Microgenics Corporation | 2019-12-16 | 59 | 0 |
| K182103 | Psychemedics Microplate EIA for Fentanyl in Hair | Psychemedics Corporation | 2019-04-18 | 258 | 0 |
| K182123 | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card | Advin Biotech, Inc. | 2019-03-29 | 235 | 0 |
| K182280 | ARK Tramadol Assay | Ark Diagnostics, Inc. | 2018-12-10 | 110 | 0 |
| K181159 | LZI Fentanyl Enzyme Immunoassay | Lin-Zhi International, Inc. | 2018-12-03 | 216 | 0 |
| K180427 | ARK Fentanyl Assay | Ark Diagnostics, Inc. | 2018-06-06 | 110 | 0 |
| K172416 | Synermed Opiate Enzyme Immunoassay | Infrared Laboratory Systems, LLC (Dba Synermed) | 2018-04-19 | 252 | 0 |
| K173195 | DRI Hydrocodone Assay | Microgenics Corporation | 2018-02-13 | 134 | 0 |
| K173183 | CEDIA Heroin Metabolite (6-AM) Assay | Microgenics Corporation | 2017-11-22 | 51 | 0 |
| K172910 | Emit II Plus Oxycodone Assay | Siemens Healthcare Diagnostics, Inc. | 2017-10-18 | 23 | 0 |
| K161216 | Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immuna | Immunalysis Corporation | 2017-06-14 | 411 | 0 |
| K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibra | Microgenics Corporation | 2017-04-06 | 150 | 0 |
| K153050 | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Te | Co-Innovation Biotech Co., Ltd. | 2016-04-26 | 189 | 0 |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtru | Chemtron Biotech, Inc. | 2016-04-18 | 167 | 0 |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign | W.H.P.M., Inc. | 2015-11-09 | 62 | 0 |
| K150606 | Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Dru | Siemens Healthcare Diagnostics, Inc. | 2015-10-23 | 227 | 0 |
| K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydr | Microgenics Corporation | 2015-10-09 | 225 | 0 |
| K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015-07-01 | 29 | 0 |
| K143502 | Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Op | Immunalysis Corporation | 2015-05-20 | 161 | 0 |
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