Atlas FDA

DIS

100 FDA 510(k) clearances · Product code

62 daysmedian time to decision
192 days90th percentile
100clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Barbiturate
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3150
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (K161714)Immunalysis Corporation2016-10-14
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup (K151211)Assure Tech. Co., Ltd.2015-06-04
Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) (K150791)Healgen Scientific,, LLC2015-04-24
CR3 Keyless Split Sample Cup Secobarbital- Methadone (K143535)Guangzhou Wondfo Biotech Co., Ltd.2015-01-13
GenPrime Snap-Top Split Key Cup (K140665)Genprime, Inc.2014-12-08
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (K140215)Co-Innovation Biotech Co., Ltd.2014-06-16
RANDOX BARITURATES ASSAY (K092268)Randox Laboratories, Ltd.2011-05-25
UCP DRUG SCREENING TEST CUPS (K110515)Ucp Biosciences, Inc.2011-04-20
AT HOME DRUG TEST MODELS, 9308T AND 9308X (K070009)Phamatech, Inc.2007-12-07
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC (K070098)Phamatech, Inc.2007-12-07
VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS (K062165)Ortho-Clinical Diagnostics2007-01-05
ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS (K050024)Guangzhou Wondfo Biotech Co., Ltd.2005-11-17
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE (K050593)ACON Laboratories, Inc.2005-05-06
ONLINE DAT BARBITURATES PLUS (K043211)Roche Diagnostics Corp.2004-12-29
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II (K042975)Ameditech, Inc.2004-12-29
RANDOX BARBITURATE ASSAY (K041143)Randox Laboratories, Ltd.2004-11-05
'RAPIDTEC 4' TEST (K041712)American Bio Medica Corp.2004-11-03
BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) (K033885)Lin-Zhi International, Inc.2004-05-19
PROFILE -ER (K033334)Medtox Diagnostics, Inc.2003-11-10
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) (K032764)Lin-Zhi International, Inc.2003-11-03
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE (K023946)ACON Laboratories, Inc.2003-02-05
VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES (K014089)Sun Biomedical Laboratories, Inc.2002-04-25
VISUALINE BARBITURATES DIPSTRIP TEST (K020136)Sun Biomedical Laboratories, Inc.2002-03-20
BARBITURATES (K012996)Abbott Laboratories2002-03-20
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE (K012824)ACON Laboratories, Inc.2001-11-09
LIVESURE BARBITURATES SCREEN TEST (K012133)Pan Probe Biotech, Inc.2001-07-20
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST (K010125)Alfa Scientific Designs, Inc.2001-05-29
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST (K003647)Alfa Scientific Designs, Inc.2001-05-29
EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 (K010934)Syva Co., Dade Behring, Inc.2001-04-20
VERDICT -II BAR; VERDICT -II BZO (K010959)Medtox Diagnostics, Inc.2001-04-13
VERDICT -II BAR/BZO (K010561)Medtox Diagnostics, Inc.2001-04-05
PROFILE-ER (K002331)Medtox Diagnostics, Inc.2001-01-17
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (K001976)OraSure Technologies, Inc.2000-12-06
BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST (K002337)Branan Medical Corporation2000-11-22
SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST (K000522)Drug Detection Devices, Ltd.2000-04-18
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A (K000459)Dade Behring, Inc.2000-04-03
RAPIDONE- BARBITURATE TEST (K992451)American Bio Medica Corp.2000-04-03
BIONIKE AQ BARBITURATE TEST (K990280)Bionike, Inc.1999-06-28
ROCHE COBAS INTEGRA SERUM BARBITURATES (K991440)Roche Diagnostics Corp.1999-06-22
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES (K983698)Roche Diagnostic Systems, Inc.1999-05-03
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR (K991018)Princeton BioMeditech Corp.1999-04-15
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP (K991076)Princeton BioMeditech Corp.1999-04-15
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO (K991082)Princeton BioMeditech Corp.1999-04-15
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD (K991084)Princeton BioMeditech Corp.1999-04-15
AUTO-LYTE BARBITURATES EIA (K982745)OraSure Technologies, Inc.1998-11-18
QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 (K982152)Phamatech1998-09-21
ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN (K982551)Roche Diagnostic Systems, Inc.1998-08-18
QUICKPAC II ONE STEP BARBITURATE TEST (K980349)Syntron Bioresearch, Inc.1998-03-03
QUIKSTRIP ONE STEP BARBITURATE TEST (K974712)Syntron Bioresearch, Inc.1998-02-12
ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST (K973047)Drial Consultants, Inc.1997-10-02
VERDICT BARBITURATES (K963529)Editek, Inc.1996-10-30
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY (K962669)Princeton BioMeditech Corp.1996-08-15
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD (K961010)Princeton BioMeditech Corp.1996-06-28
BARBITURATE SERUM TOX EIA ASSAY (K960664)Diagnostic Reagents, Inc.1996-05-06
BARBITURATE EIA ESSAY (MODIFICATION) (K955928)Diagnostic Reagents, Inc.1996-03-11
ACS PHENOBARBITAL (K953021)Ciba Corning Diagnostics Corp.1995-12-11
AXSYM BARBITURATES II U (K951253)Abbott Laboratories1995-05-18
URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE (K950137)E.I. Dupont DE Nemours & Co., Inc.1995-04-13
EMIT IIC BARBITURATE ASSAY (K935116)Syva Co.1995-02-22
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST (K944075)Beckman Instruments, Inc.1994-12-29
CEDIA DAU BARBITURATE ASSAY (K945344)Microgenics Corp.1994-12-28
CEDIA DAU BARBITURATE ASSAY (K942436)Microgenics Corp.1994-08-30
CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION (K942404)Microgenics Corp.1994-07-28
ACE CLINICAL CHEMISTRY SYSTEM (K941489)Schiapparelli Biosystems, Inc.1994-07-18
CEDIA DAU BARBITURATE ASSAY (K936030)Microgenics Corp.1994-03-22
STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA (K934376)Solarcare, Inc.1993-12-07
MICROLINE SCREEN FOR BARBITURATES (K933480)Drug Screening Systems, Inc.1993-10-29
EMIT(R) D.A.U. BARBITURATE ASSAY (K931535)Syva Co.1993-06-15
EMIT(R) II BARBITURATE ASSAY (K926068)Syva Co.1993-01-12
BARBITURATE EIA TEST (K925491)Diagnostic Reagents, Inc.1992-12-30
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL (K920525)Biotrack, Inc.1992-08-05
IL TEST BARBITURATE, 35289 (K920417)Instrumentation Laboratory CO1992-04-24
TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) (K920314)Syntex Corp.1992-04-17
EZ-SCREEN:BARBITURATES (K905057)Environmental Diagnostics, Inc.1990-11-28
DRUG OF ABUSE ANALYSIS SYSTEM (K903825)Technicon Instruments Corp.1990-09-27
EMIT(R) II BARBITURATE ASSAY (K902580)Syva Co.1990-07-19
TDX(R) BARBITURATES II ASSAY (K896550)Abbott Laboratories1989-12-19
ADX TM BARBITURATES (K890690)Abbott Laboratories1989-08-25
TDX BARBITURATES SERUM (K892650)Abbott Laboratories1989-05-16
ABUSCREEN FP FOR BARBITURATES (K890884)Roche Diagnostic Systems, Inc.1989-03-09
BARBITURATE ENZYME IMMUNOASSAY KIT (K882663)General Diagnostics1988-09-19
EMIT HVA BARBITURATE ASSAY (K882611)Syva Co.1988-08-08
REVISED LABELING FOR ADX BARBITURATES (K880012)Abbott Laboratories1988-03-01
REVISED LABELING FOR SYVA BARBITURATE ASSAYS (K874702)Syva Co.1988-01-05
REVISED LABELING FOR TDX BARBITURATES (K874483)Abbott Laboratories1987-11-23
REVISED LABELING FOR ABUSCREEN EIA BARBITURATE (K874210)Roche Diagnostic Systems, Inc.1987-11-13
REVISED LABELING FOR BARBITURATE TEST KIT (K874266)Roche Diagnostic Systems, Inc.1987-11-13
ACA URINE BARBITURATES SCREEN METHOD (K873623)E.I. Dupont DE Nemours & Co., Inc.1987-10-20
LABELING CHANGE BARBITURATES IN URINE (K873754)Diagnostic Products Corp.1987-10-15
QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE (K864993)General Diagnostics1987-03-31
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5 (K870936)Diagnostic Products Corp.1987-03-19
ABUSCREEN (R) EIA BARBITURATE (K870378)Roche Diagnostic Systems, Inc.1987-03-16
EMIT D.A.U. BARBITURATE ASSAY (K842675)Syva Co.1984-09-26
EMIT 700 BARBITURATE ASSAY (K843418)Syva Co.1984-09-14
ACA BARBITURATES SCREEN ANALY TEST PACK (K842783)E.I. Dupont DE Nemours & Co., Inc.1984-09-07
EMIT ST SERUM BARBITURATE ASSAY (K840194)Syva Co.1984-03-19
MODIF. OF EMIT URINE BARBITURATE (K833577)Syva Co.1984-01-26
EMIT-ST SERUM BARBITURATE ASSAY (K810602)Syva Co.1981-04-03
EMIT-STM BARBITURATE ASSAY (K802617)Syva Co.1980-10-31
EMIT-BARBITURATE ASSAY (K792114)Syva Co.1979-12-04

Track DIS automatically

Every clearance here is in the API, with alerts when new ones post.