Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DIS — Predicate Candidate Screening
100 FDA 510(k) clearances under this product code; the 50 most recent screened below.
62 daysmedian FDA review time
192 days90th percentile
100clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalys | Immunalysis Corporation | 2016-10-14 | 115 | 0 |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, A | Assure Tech. Co., Ltd. | 2015-06-04 | 29 | 0 |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), H | Healgen Scientific,, LLC | 2015-04-24 | 30 | 0 |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | Guangzhou Wondfo Biotech Co., Ltd. | 2015-01-13 | 29 | 0 |
| K140665 | GenPrime Snap-Top Split Key Cup | Genprime, Inc. | 2014-12-08 | 265 | 0 |
| K140215 | ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD | Co-Innovation Biotech Co., Ltd. | 2014-06-16 | 139 | 0 |
| K092268 | RANDOX BARITURATES ASSAY | Randox Laboratories, Ltd. | 2011-05-25 | 666 | 0 |
| K110515 | UCP DRUG SCREENING TEST CUPS | Ucp Biosciences, Inc. | 2011-04-20 | 56 | 0 |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | Phamatech, Inc. | 2007-12-07 | 338 | 0 |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 901 | Phamatech, Inc. | 2007-12-07 | 331 | 0 |
| K062165 | VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; F | Ortho-Clinical Diagnostics | 2007-01-05 | 161 | 0 |
| K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | Guangzhou Wondfo Biotech Co., Ltd. | 2005-11-17 | 316 | 0 |
| K050593 | ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE | ACON Laboratories, Inc. | 2005-05-06 | 59 | 0 |
| K043211 | ONLINE DAT BARBITURATES PLUS | Roche Diagnostics Corp. | 2004-12-29 | 40 | 0 |
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | Ameditech, Inc. | 2004-12-29 | 62 | 3 |
| K041143 | RANDOX BARBITURATE ASSAY | Randox Laboratories, Ltd. | 2004-11-05 | 189 | 0 |
| K041712 | 'RAPIDTEC 4' TEST | American Bio Medica Corp. | 2004-11-03 | 133 | 0 |
| K033885 | BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT | Lin-Zhi International, Inc. | 2004-05-19 | 156 | 0 |
| K033334 | PROFILE -ER | Medtox Diagnostics, Inc. | 2003-11-10 | 25 | 0 |
| K032764 | BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); | Lin-Zhi International, Inc. | 2003-11-03 | 59 | 1 |
| K023946 | ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON O | ACON Laboratories, Inc. | 2003-02-05 | 70 | 0 |
| K014089 | VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES | Sun Biomedical Laboratories, Inc. | 2002-04-25 | 135 | 0 |
| K020136 | VISUALINE BARBITURATES DIPSTRIP TEST | Sun Biomedical Laboratories, Inc. | 2002-03-20 | 64 | 0 |
| K012996 | BARBITURATES | Abbott Laboratories | 2002-03-20 | 195 | 0 |
| K012824 | ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP | ACON Laboratories, Inc. | 2001-11-09 | 78 | 0 |
| K012133 | LIVESURE BARBITURATES SCREEN TEST | Pan Probe Biotech, Inc. | 2001-07-20 | 11 | 0 |
| K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 183 | 0 |
| K003647 | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 | 183 | 0 |
| K010934 | EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 | Syva Co., Dade Behring, Inc. | 2001-04-20 | 23 | 0 |
| K010959 | VERDICT -II BAR; VERDICT -II BZO | Medtox Diagnostics, Inc. | 2001-04-13 | 14 | 0 |
| K010561 | VERDICT -II BAR/BZO | Medtox Diagnostics, Inc. | 2001-04-05 | 38 | 0 |
| K002331 | PROFILE-ER | Medtox Diagnostics, Inc. | 2001-01-17 | 169 | 0 |
| K001976 | STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I | OraSure Technologies, Inc. | 2000-12-06 | 160 | 1 |
| K002337 | BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN | Branan Medical Corporation | 2000-11-22 | 113 | 0 |
| K000522 | SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST | Drug Detection Devices, Ltd. | 2000-04-18 | 62 | 0 |
| K000459 | URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CAT | Dade Behring, Inc. | 2000-04-03 | 52 | 0 |
| K992451 | RAPIDONE- BARBITURATE TEST | American Bio Medica Corp. | 2000-04-03 | 256 | 0 |
| K990280 | BIONIKE AQ BARBITURATE TEST | Bionike, Inc. | 1999-06-28 | 151 | 0 |
| K991440 | ROCHE COBAS INTEGRA SERUM BARBITURATES | Roche Diagnostics Corp. | 1999-06-22 | 57 | 0 |
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | Roche Diagnostic Systems, Inc. | 1999-05-03 | 194 | 0 |
| K991018 | ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991076 | ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991082 | ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS D | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K991084 | ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/B | Princeton BioMeditech Corp. | 1999-04-15 | 20 | 0 |
| K982745 | AUTO-LYTE BARBITURATES EIA | OraSure Technologies, Inc. | 1998-11-18 | 104 | 0 |
| K982152 | QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021 | Phamatech | 1998-09-21 | 95 | 0 |
| K982551 | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABU | Roche Diagnostic Systems, Inc. | 1998-08-18 | 27 | 0 |
| K980349 | QUICKPAC II ONE STEP BARBITURATE TEST | Syntron Bioresearch, Inc. | 1998-03-03 | 34 | 0 |
| K974712 | QUIKSTRIP ONE STEP BARBITURATE TEST | Syntron Bioresearch, Inc. | 1998-02-12 | 57 | 0 |
| K973047 | ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST | Drial Consultants, Inc. | 1997-10-02 | 48 | 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