Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DIO — Predicate Candidate Screening
145 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
280 days90th percentile
145clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite E | Carolina Liquid Chemistries Corp. | 2022-01-27 | 120 | 0 |
| K211973 | DRI Cocaine Metabolite Assay | Microgenics Corporation | 2021-09-24 | 91 | 0 |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | Medtest DX | 2020-03-12 | 267 | 0 |
| K181499 | DRI Cocaine Metabolite Assay | Microgenics Corporation | 2018-07-06 | 29 | 0 |
| K170293 | Emit II Plus Cocaine Metabolite Assay | Siemens Healthcare Diagnostics, Inc. | 2017-10-25 | 267 | 0 |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite T | Carolina Liquid Chemistries Corporation | 2017-08-15 | 239 | 0 |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | Mp Biomedicals, LLC | 2017-06-02 | 280 | 0 |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine) | Quest Diagnostics Incorporated | 2016-11-18 | 469 | 0 |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo | Guangzhou Wondfo Biotech Co., Ltd. | 2016-06-27 | 59 | 0 |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine | Safecare Biotech (Hangzhou) Co., Ltd. | 2016-03-18 | 88 | 0 |
| K142129 | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID | Biophor Diagnostics, Inc. | 2015-07-24 | 354 | 0 |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immuna | Immunalysis Corporation | 2015-06-29 | 84 | 0 |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Ab | W.H.P.M., Inc. | 2014-10-07 | 47 | 0 |
| K141647 | HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP | Healgen Scientific,, LLC | 2014-07-17 | 28 | 0 |
| K131128 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND | Omega Laboratories, Inc. | 2013-11-13 | 204 | 0 |
| K131754 | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URI | Guangzhou Wondfo Biotech Co., Ltd. | 2013-07-31 | 47 | 0 |
| K113751 | RANDOX COCAINE METABOLITE | Randox Laboratories, Ltd. | 2012-05-08 | 139 | 0 |
| K121166 | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TES | Guangzhou Wondfo Biotech Co., Ltd. | 2012-05-08 | 21 | 0 |
| K103227 | ORATECT ORAL FLUID DRUG SCREEN DEVICES | Branan Medical Corporation | 2012-04-11 | 527 | 0 |
| K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST | Phamatech, Inc. | 2012-02-01 | 450 | 0 |
| K112808 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND | Omega Laboratories, Inc. | 2012-01-23 | 118 | 0 |
| K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) | Ameditech, Inc. | 2011-12-05 | 10 | 0 |
| K113139 | LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBR | Lin-Zhi International, Inc. | 2011-11-22 | 29 | 0 |
| K112071 | WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAM | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-23 | 65 | 0 |
| K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY | Microgenics Corp. | 2011-04-08 | 290 | 0 |
| K101160 | ROCHE ORAL FLUID COCAINE | Roche Diagnostics | 2011-02-11 | 291 | 0 |
| K080436 | RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 90 | Quantrx Biomedical Corporation | 2009-02-11 | 358 | 0 |
| K062929 | QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA | Quest Diagnostics, Inc. | 2006-12-18 | 81 | 0 |
| K062123 | VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, F | Ortho-Clinical Diagnostics, Inc. | 2006-11-16 | 114 | 1 |
| K053422 | RAPIDONE-COCAINE-150 TEST | American Bio Medica Corp. | 2006-06-15 | 189 | 0 |
| K053035 | ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# | Acro Biotech, LLC | 2006-05-05 | 190 | 0 |
| K050945 | ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY | Lin-Zhi International, Inc. | 2006-03-29 | 349 | 0 |
| K051578 | IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS | Immunalysis Corporation | 2005-11-18 | 157 | 0 |
| K050465 | IMMUNALYSIS COCAINE ELISA FOR HAIR | Immunalysis Corporation | 2005-08-04 | 154 | 0 |
| K050321 | ONTRAK TESTCARD 9 | Varian, Inc. | 2005-04-18 | 68 | 0 |
| K033866 | CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 ( | Lin-Zhi International, Inc. | 2004-04-07 | 117 | 0 |
| K040198 | LABONE COCAINE METABOLITE MICRO-PLATE EIA | Labone, Inc. | 2004-03-05 | 36 | 0 |
| K032903 | ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE | ACON Laboratories, Inc. | 2004-02-17 | 153 | 0 |
| K033713 | URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATA | Dade Behring, Inc. | 2004-02-09 | 75 | 0 |
| K030360 | RANDOX EVIDENCE | Randox Laboratories, Ltd. | 2003-12-23 | 323 | 0 |
| K023626 | AML HAIRCHECK-DT (COCAINE) | Quest Diagnostics, Inc. | 2003-09-29 | 335 | 0 |
| K032057 | TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC | Branan Medical Corp. | 2003-08-21 | 50 | 1 |
| K031512 | EMIT II PLUS COCAINE METABOLITE ASSAY | Dade Behring, Inc. | 2003-07-23 | 70 | 0 |
| K030234 | COZART EIA COCAINE ORAL FLIUD KIT | Cozart Bioscience , Ltd. | 2003-04-28 | 95 | 0 |
| K023489 | QUICKTOX MULTIPLE DRUG DIPCARD | Branan Medical Corp. | 2002-12-16 | 60 | 0 |
| K023281 | ONLINE DAT II COCAINE II | Roche Diagnostics Corp. | 2002-12-06 | 66 | 0 |
| K023296 | COBAS INTEGRA ONLINE DAT II COCAINE II | Roche Diagnostics Corp. | 2002-11-25 | 54 | 0 |
| K022954 | AMEDICA DRUG SCREEN COCAINE TEST | Amedica Biotech, Inc. | 2002-11-06 | 62 | 0 |
| K022355 | QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/M | Branan Medical Corp. | 2002-07-30 | 11 | 1 |
| K014067 | LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), | Princeton BioMeditech Corp. | 2002-06-10 | 182 | 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