Product Code: DIS FDA class 2 21 CFR 862.3150

Enzyme Immunoassay, Barbiturate

Clinical Toxicology

The Enzyme Immunoassay for Barbiturate is a laboratory test using antibody-based enzyme immunoassay technology to screen for and quantify barbiturate compounds in biological specimens such as urine or serum, supporting emergency toxicology and drug monitoring applications. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3150 within the Clinical Toxicology specialty. This device qualifies for third-party 510(k) review.

View on FDA

510(k)s

100

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code DIS in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: DIS
Device Class: FDA class 2
Regulation Number: 862.3150
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 100 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K161714	Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators	Oct 14, 2016	Substantially Equivalent	Immunalysis Corporation
K151211	AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup	Jun 04, 2015	Substantially Equivalent	Assure Tech. Co., Ltd.
K150791	Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)	Apr 24, 2015	Substantially Equivalent	Healgen Scientific,, LLC
K143535	CR3 Keyless Split Sample Cup Secobarbital- Methadone	Jan 13, 2015	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K140665	GenPrime Snap-Top Split Key Cup	Dec 08, 2014	Substantially Equivalent	Genprime, Inc.
K140215	ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD	Jun 16, 2014	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.
K092268	RANDOX BARITURATES ASSAY	May 25, 2011	Substantially Equivalent	Randox Laboratories, Ltd.
K110515	UCP DRUG SCREENING TEST CUPS	Apr 20, 2011	Substantially Equivalent	Ucp Biosciences, Inc.
K070098	QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC	Dec 07, 2007	Substantially Equivalent	Phamatech, Inc.
K070009	AT HOME DRUG TEST MODELS, 9308T AND 9308X	Dec 07, 2007	Substantially Equivalent	Phamatech, Inc.
K062165	VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS	Jan 05, 2007	Substantially Equivalent	Ortho-Clinical Diagnostics
K050024	ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS	Nov 17, 2005	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.
K050593	ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE	May 06, 2005	Substantially Equivalent	ACON Laboratories, Inc.
K043211	ONLINE DAT BARBITURATES PLUS	Dec 29, 2004	Substantially Equivalent	Roche Diagnostics Corp.
K042975	AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II	Dec 29, 2004	Substantially Equivalent	Ameditech, Inc.
K041143	RANDOX BARBITURATE ASSAY	Nov 05, 2004	Substantially Equivalent	Randox Laboratories, Ltd.
K041712	'RAPIDTEC 4' TEST	Nov 03, 2004	Substantially Equivalent	American Bio Medica Corp.
K033885	BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT)	May 19, 2004	Substantially Equivalent	Lin-Zhi International, Inc.
K033334	PROFILE -ER	Nov 10, 2003	Substantially Equivalent	Medtox Diagnostics, Inc.
K032764	BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)	Nov 03, 2003	Substantially Equivalent	Lin-Zhi International, Inc.
K023946	ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE	Feb 05, 2003	Substantially Equivalent	ACON Laboratories, Inc.
K014089	VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES	Apr 25, 2002	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K020136	VISUALINE BARBITURATES DIPSTRIP TEST	Mar 20, 2002	Substantially Equivalent	Sun Biomedical Laboratories, Inc.
K012996	BARBITURATES	Mar 20, 2002	Substantially Equivalent	Abbott Laboratories
K012824	ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE	Nov 09, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K012133	LIVESURE BARBITURATES SCREEN TEST	Jul 20, 2001	Substantially Equivalent	Pan Probe Biotech, Inc.
K010125	INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K003647	INSTANT-VIEW BARBITURATE URINE CASSETTE TEST	May 29, 2001	Substantially Equivalent	Alfa Scientific Designs, Inc.
K010934	EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229	Apr 20, 2001	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K010959	VERDICT -II BAR; VERDICT -II BZO	Apr 13, 2001	Substantially Equivalent	Medtox Diagnostics, Inc.
K010561	VERDICT -II BAR/BZO	Apr 05, 2001	Substantially Equivalent	Medtox Diagnostics, Inc.
K002331	PROFILE-ER	Jan 17, 2001	Substantially Equivalent	Medtox Diagnostics, Inc.
K001976	STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I	Dec 06, 2000	Substantially Equivalent	OraSure Technologies, Inc.
K002337	BRANAN MEDICAL CORPORATION MONITECT BARBITURATES DRUG SCREEN TEST	Nov 22, 2000	Substantially Equivalent	Branan Medical Corporation
K000522	SCREENERS BARBITURATE TEST, DRUGSCREEN DIP BARBITURATE TEST	Apr 18, 2000	Substantially Equivalent	Drug Detection Devices, Ltd.
K992451	RAPIDONE- BARBITURATE TEST	Apr 03, 2000	Substantially Equivalent	American Bio Medica Corp.
K000459	URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A	Apr 03, 2000	Substantially Equivalent	Dade Behring, Inc.
K990280	BIONIKE AQ BARBITURATE TEST	Jun 28, 1999	Substantially Equivalent	Bionike, Inc.
K991440	ROCHE COBAS INTEGRA SERUM BARBITURATES	Jun 22, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K983698	MODIFICATION TO ABUSCREEN ONLINE BARBITURATES	May 03, 1999	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K991084	ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD	Apr 15, 1999	Substantially Equivalent	Princeton BioMeditech Corp.
K991082	ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO	Apr 15, 1999	Substantially Equivalent	Princeton BioMeditech Corp.
K991076	ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP	Apr 15, 1999	Substantially Equivalent	Princeton BioMeditech Corp.
K991018	ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR	Apr 15, 1999	Substantially Equivalent	Princeton BioMeditech Corp.
K982745	AUTO-LYTE BARBITURATES EIA	Nov 18, 1998	Substantially Equivalent	OraSure Technologies, Inc.
K982152	QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152	Sep 21, 1998	Substantially Equivalent	Phamatech
K982551	ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN	Aug 18, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K980349	QUICKPAC II ONE STEP BARBITURATE TEST	Mar 03, 1998	Substantially Equivalent	Syntron Bioresearch, Inc.
K974712	QUIKSTRIP ONE STEP BARBITURATE TEST	Feb 12, 1998	Substantially Equivalent	Syntron Bioresearch, Inc.
K973047	ONE STEP URINE DRUG OF ABUSE BARBITURATE TEST	Oct 02, 1997	Substantially Equivalent	Drial Consultants, Inc.
K963529	VERDICT BARBITURATES	Oct 30, 1996	Substantially Equivalent	Editek, Inc.
K962669	ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY	Aug 15, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K961010	ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD	Jun 28, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K960664	BARBITURATE SERUM TOX EIA ASSAY	May 06, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K955928	BARBITURATE EIA ESSAY (MODIFICATION)	Mar 11, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K953021	ACS PHENOBARBITAL	Dec 11, 1995	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K951253	AXSYM BARBITURATES II U	May 18, 1995	Substantially Equivalent	Abbott Laboratories
K950137	URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE	Apr 13, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K935116	EMIT IIC BARBITURATE ASSAY	Feb 22, 1995	Substantially Equivalent	Syva Co.
K944075	CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST	Dec 29, 1994	Substantially Equivalent	Beckman Instruments, Inc.
K945344	CEDIA DAU BARBITURATE ASSAY	Dec 28, 1994	Substantially Equivalent	Microgenics Corp.
K942436	CEDIA DAU BARBITURATE ASSAY	Aug 30, 1994	Substantially Equivalent	Microgenics Corp.
K942404	CEDIA(R) DAU BARBITURATE ASSAY, MODIFICATION	Jul 28, 1994	Substantially Equivalent	Microgenics Corp.
K941489	ACE CLINICAL CHEMISTRY SYSTEM	Jul 18, 1994	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K936030	CEDIA DAU BARBITURATE ASSAY	Mar 22, 1994	Substantially Equivalent	Microgenics Corp.
K934376	STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA	Dec 07, 1993	Substantially Equivalent	Solarcare, Inc.
K933480	MICROLINE SCREEN FOR BARBITURATES	Oct 29, 1993	Substantially Equivalent	Drug Screening Systems, Inc.
K931535	EMIT(R) D.A.U. BARBITURATE ASSAY	Jun 15, 1993	Substantially Equivalent	Syva Co.
K926068	EMIT(R) II BARBITURATE ASSAY	Jan 12, 1993	Substantially Equivalent	Syva Co.
K925491	BARBITURATE EIA TEST	Dec 30, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K920525	BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL	Aug 05, 1992	Substantially Equivalent	Biotrack, Inc.
K920417	IL TEST BARBITURATE, 35289	Apr 24, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K920314	TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)	Apr 17, 1992	Substantially Equivalent	Syntex Corp.
K905057	EZ-SCREEN:BARBITURATES	Nov 28, 1990	Substantially Equivalent	Environmental Diagnostics, Inc.
K903825	DRUG OF ABUSE ANALYSIS SYSTEM	Sep 27, 1990	Substantially Equivalent	Technicon Instruments Corp.
K902580	EMIT(R) II BARBITURATE ASSAY	Jul 19, 1990	Substantially Equivalent	Syva Co.
K896550	TDX(R) BARBITURATES II ASSAY	Dec 19, 1989	Substantially Equivalent	Abbott Laboratories
K890690	ADX TM BARBITURATES	Aug 25, 1989	Substantially Equivalent	Abbott Laboratories
K892650	TDX BARBITURATES SERUM	May 16, 1989	Substantially Equivalent	Abbott Laboratories
K890884	ABUSCREEN FP FOR BARBITURATES	Mar 09, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K882663	BARBITURATE ENZYME IMMUNOASSAY KIT	Sep 19, 1988	Substantially Equivalent	General Diagnostics
K882611	EMIT HVA BARBITURATE ASSAY	Aug 08, 1988	Substantially Equivalent	Syva Co.
K880012	REVISED LABELING FOR ADX BARBITURATES	Mar 01, 1988	Substantially Equivalent	Abbott Laboratories
K874702	REVISED LABELING FOR SYVA BARBITURATE ASSAYS	Jan 05, 1988	Substantially Equivalent	Syva Co.
K874483	REVISED LABELING FOR TDX BARBITURATES	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K874266	REVISED LABELING FOR BARBITURATE TEST KIT	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K874210	REVISED LABELING FOR ABUSCREEN EIA BARBITURATE	Nov 13, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K873623	ACA URINE BARBITURATES SCREEN METHOD	Oct 20, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K873754	LABELING CHANGE BARBITURATES IN URINE	Oct 15, 1987	Substantially Equivalent	Diagnostic Products Corp.
K864993	QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE	Mar 31, 1987	Substantially Equivalent	General Diagnostics
K870936	COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5	Mar 19, 1987	Substantially Equivalent	Diagnostic Products Corp.
K870378	ABUSCREEN (R) EIA BARBITURATE	Mar 16, 1987	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K842675	EMIT D.A.U. BARBITURATE ASSAY	Sep 26, 1984	Substantially Equivalent	Syva Co.
K843418	EMIT 700 BARBITURATE ASSAY	Sep 14, 1984	Substantially Equivalent	Syva Co.
K842783	ACA BARBITURATES SCREEN ANALY TEST PACK	Sep 07, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K840194	EMIT ST SERUM BARBITURATE ASSAY	Mar 19, 1984	Substantially Equivalent	Syva Co.
K833577	MODIF. OF EMIT URINE BARBITURATE	Jan 26, 1984	Substantially Equivalent	Syva Co.
K810602	EMIT-ST SERUM BARBITURATE ASSAY	Apr 03, 1981	Substantially Equivalent	Syva Co.
K802617	EMIT-STM BARBITURATE ASSAY	Oct 31, 1980	Substantially Equivalent	Syva Co.
K792114	EMIT-BARBITURATE ASSAY	Dec 04, 1979	Substantially Equivalent	Syva Co.