Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DJR — Predicate Candidate Screening
63 FDA 510(k) clearances under this product code; the 50 most recent screened below.
76 daysmedian FDA review time
279 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192433 | LZI Methadone II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019-10-04 | 29 | 0 |
| K182779 | ARK EDDP Assay | Ark Diagnostics, Inc. | 2018-11-21 | 51 | 0 |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone M | Lin-Zhi International, Inc. | 2017-06-26 | 136 | 0 |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortript | W.H.P.M., Inc. | 2016-08-17 | 147 | 0 |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, | Assure Tech. Co., Ltd. | 2015-10-05 | 75 | 0 |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunaly | Immunalysis Corporation | 2015-07-24 | 59 | 0 |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of A | W.H.P.M., Inc. | 2015-06-29 | 31 | 0 |
| K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URIN | Guangzhou Wondfo Biotech Co., Ltd. | 2013-05-31 | 30 | 0 |
| K092272 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | 2010-11-18 | 478 | 0 |
| K092258 | RANDOX METABOLITE (EDDP) ASSAY | Randox Laboratories, Ltd. | 2010-11-09 | 469 | 0 |
| K092048 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP | Biosite Incorporated | 2010-04-19 | 286 | 0 |
| K081378 | DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CO | Thermo Fisher Scientific | 2009-01-14 | 243 | 0 |
| K062637 | VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, D | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 | 78 | 0 |
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 | Biosite Incorporated | 2006-06-22 | 91 | 5 |
| K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | W.H.P.M., Inc. | 2006-06-09 | 301 | 0 |
| K051058 | METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRA | Lin-Zhi International, Inc. | 2006-03-29 | 337 | 0 |
| K040570 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | 2004-05-10 | 67 | 0 |
| K031797 | METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 | Lin-Zhi International, Inc. | 2003-10-10 | 122 | 0 |
| K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY | Microgenics Corp. | 2003-08-27 | 302 | 0 |
| K023856 | VISUALINE METHADONE DIPSTRIPTEST | Sun Biomedical Laboratories, Inc. | 2003-08-25 | 279 | 0 |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST | American Bio Medica Corp. | 2003-04-30 | 161 | 0 |
| K023317 | METHADONE ENZYME IMMUNOASSAY | Lin-Zhi International, Inc. | 2002-12-12 | 70 | 0 |
| K023252 | RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TES | Icn Biomedicals, Inc. | 2002-11-22 | 53 | 0 |
| K021505 | ONLINE DAT II METHADONE II | Roche Diagnostics Corp. | 2002-07-16 | 68 | 0 |
| K021512 | COBAS INTEGRA ONLINE DAT II METHADONE II | Roche Diagnostics Corp. | 2002-07-16 | 68 | 0 |
| K013001 | METHADONE | Abbott Laboratories | 2002-03-20 | 195 | 0 |
| K013796 | LIVESURE METHADONE SCREEN TESTS | Pan Probe Biotech, Inc. | 2001-11-26 | 11 | 0 |
| K012164 | 'RAPIDONE'-METHADONE TEST | American Bio Medica Corp. | 2001-11-20 | 132 | 0 |
| K012595 | ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE | ACON Laboratories, Inc. | 2001-10-15 | 66 | 0 |
| K011131 | METHADONE MICROPLATE EIA URINE APPLICATION | Cozart Bioscience , Ltd. | 2001-07-31 | 109 | 0 |
| K010014 | INSTANT-VIEW METHADONE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 147 | 0 |
| K010015 | INSTANT-VIEW METHADONE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 147 | 0 |
| K010962 | EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 | Syva Co., Dade Behring, Inc. | 2001-04-26 | 27 | 0 |
| K002010 | STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 | OraSure Technologies, Inc. | 2000-11-29 | 149 | 0 |
| K002417 | BRANAN MEDICAL CORPORATION MONITECT METHADONE DRUG SCREEN TE | Branan Medical Corporation | 2000-11-22 | 106 | 0 |
| K000466 | URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALO | Dade Behring, Inc. | 2000-04-05 | 54 | 0 |
| K994005 | SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL | Syva Co. | 2000-01-20 | 57 | 0 |
| K991080 | ACCUSIGN MTD, BIOSIGN MTD | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K982938 | QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QU | Phamatech | 1999-02-05 | 168 | 0 |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | Roche Diagnostic Systems, Inc. | 1998-12-11 | 51 | 0 |
| K981314 | VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE | Sun Biomedical Laboratories, Inc. | 1998-09-04 | 147 | 0 |
| K980746 | CEDIA DAU EDDP ASSAY | Boehringer Mannheim Corp. | 1998-05-26 | 89 | 0 |
| K973069 | SYNCHRON SYSTEMS METHADONE REAGENT | Beckman Instruments, Inc. | 1997-09-22 | 35 | 0 |
| K972526 | METHADONE EIA ASSAY | Diagnostic Reagents, Inc. | 1997-08-04 | 39 | 0 |
| K962673 | ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY | Princeton BioMeditech Corp. | 1996-08-15 | 37 | 0 |
| K954227 | CEDIA DAU METHADONE ASSAY | Microgenics Corp. | 1995-11-17 | 67 | 0 |
| K953499 | AXSYM METHADONE | Abbott Laboratories | 1995-11-13 | 110 | 0 |
| K944056 | AUTO-LYTE METHADONE DIA | Solarcare Technologies Corp,Inc. | 1994-12-29 | 132 | 0 |
| K944074 | CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST | Beckman Instruments, Inc. | 1994-12-02 | 150 | 0 |
| K934667 | METHADONE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1994-01-26 | 119 | 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