Product Code: LAS FDA class 1 21 CFR 862.3280

Drug Specific Control Materials

Clinical Toxicology

Drug-specific control materials are reference materials used in clinical toxicology laboratories to calibrate and validate assay systems that measure drug concentrations in patient specimens. They are classified as FDA Class 1, the lowest risk tier, requiring only general controls such as proper labeling and good manufacturing practices, with no premarket notification required. The product code is LAS, regulated under 21 CFR 862.3280, in the Clinical Toxicology specialty. No special risk flags apply to this device.

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FEI Numbers

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Unique Applicants

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Basic Information

Product Code: LAS
Device Class: FDA class 1
Regulation Number: 862.3280
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 83 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K080459	CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS	Nov 17, 2009	Substantially Equivalent	Chromsystems Instruments & Chemicals GmbH
K072257	MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL	Jan 30, 2008	Substantially Equivalent	More Diagnostics
K062942	QUANTIMETRIX NICOSURE COTININE URINE CONTROL	Oct 30, 2006	Substantially Equivalent	Quantimetrix Corp.
K051074	MAS IMMUNOSUPPRESSANT CONTROLS	Jun 06, 2005	Substantially Equivalent	Microgenics Corp.
K040411	DRI OXYCODONE ASSAY	May 27, 2004	Substantially Equivalent	Microgenics Corp.
K032842	MICROGENICS CYCLOSPORINE CONTROL KIT	Oct 17, 2003	Substantially Equivalent	Microgenics Corp.
K030616	CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5	Mar 31, 2003	Substantially Equivalent	Microgenics Corp.
K992151	REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE	Jul 14, 1999	Substantially Equivalent	Consolidated Technologies, Inc.
K970517	INNOFLUOR TOPIRAMATE CONTROL SET	May 12, 1997	Substantially Equivalent	Oxis Intl., Inc.
K971210	SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS	Apr 17, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K946119	ROCHE-TDM ONLEIN(TM) CONTROLS	Feb 07, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K943048	MICROGENICS THC CONTROL SETS	Aug 24, 1994	Substantially Equivalent	Microgenics Corp.
K930844	ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE	Jan 27, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K934145	DUPONT ACA URINE METHADONE CONTROL	Nov 09, 1993	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K933557	REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE	Sep 10, 1993	Substantially Equivalent	Consolidated Technologies, Inc.
K932662	CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL	Jul 26, 1993	Substantially Equivalent	More Diagnostics
K921939	SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)	Jul 16, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K921141	CANNABINOID URINE CONTROLS	Apr 17, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K915516	ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL	Jan 28, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K913677	ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III	Sep 25, 1991	Substantially Equivalent	Analytical Control Systems, Inc.
K913336	ABUSCREEN(R) ONLINE(TM) CONTROLS	Aug 26, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K913107	ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ	Aug 12, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K903061	UTAK LABORATORIES TOXICOLOGY CONTROL	Apr 12, 1991	Substantially Equivalent	Utak Laboratories, Inc.
K910829	LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2	Apr 03, 1991	Substantially Equivalent	Bio-Rad
K910689	ABUSCREEN(R) ONLINE CONTROLS	Mar 11, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K894464	ABUSCREEN POSITIVE REFERENCE CONTROLS	Aug 28, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K894463	ABUSCREEN TRI-LEVEL REFERENCE CONTROLS	Aug 21, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K893860	ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE	Aug 03, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K893859	ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE	Aug 03, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K893858	ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC	Aug 03, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K893857	ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE	Aug 03, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K893856	ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE	Aug 03, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K893855	ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES	Aug 03, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K892004	LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3	Apr 21, 1989	Substantially Equivalent	Bio-Rad
K883891	DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER	Nov 29, 1988	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K873011	QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2	Oct 29, 1987	Substantially Equivalent	Quantimetrix Medical Industries
K872347	DIGOXIN FPIA CONTROLS	Jul 07, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K871567	PHENYTOIN FPIA CONTROLS	Jul 01, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K864456	CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3	May 06, 1987	Substantially Equivalent	Cala Diagnostics
K862419	SERUM VANCOMYCIN TOXICOLOGY CONTROL	Nov 13, 1986	Substantially Equivalent	Utak Laboratories, Inc.
K862418	BENZODIAZEPINES TOXICOLOGY CONTROL	Nov 13, 1986	Substantially Equivalent	Utak Laboratories, Inc.
K862421	SERUM CLONAZEPAM TOXICOLOGY CONTROL	Nov 05, 1986	Substantially Equivalent	Utak Laboratories, Inc.
K863117	HIGH PERFORMANCE CANNABINOID CONTROLS	Sep 25, 1986	Substantially Equivalent	Rapid Diagnostic Laboratories, Inc.
K861511	EMIT CAFFEINE CONTROL	Jun 13, 1986	Substantially Equivalent	Syva / A Syntex Co.
K843419	EMIT 700 CANNABINOID CONTROL SET	Oct 05, 1984	Substantially Equivalent	Syva Co.
K841533	ACA TRICYCLIC ANTIDEPRESSANTS SCREEN	May 11, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K831738	CAFFINE TOXICOLOGY CONTROL	Jul 26, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831735	MAPROTILINE	Jul 26, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831979	EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO	Jul 19, 1983	Substantially Equivalent	Syva Co.
K831739	PENTOBARBITAL TOXICOLOGY CONTROL	Jul 06, 1983	Substantially Equivalent	Utak Laboratories, Inc.
K831417	EMIT QST TOBRAMYCIN CONTROL	Jun 16, 1983	Substantially Equivalent	Syva Co.
K830049	ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL	Jan 28, 1983	Substantially Equivalent	Syva Co.
K823369	ADVANCE EMIT(R) & TM AMIKACIN CONTROL	Dec 15, 1982	Substantially Equivalent	Syva Co.
K822934	SYVA ADVANCE EMIT AED VALPROIC ACID CONT	Oct 27, 1982	Substantially Equivalent	Syva Co.
K821766	EMIT - ST URINE METHAGUALONE CONTROLS	Jun 24, 1982	Substantially Equivalent	Syva Co.
K821380	EMIT TOX ACETAMINOPHEN CONTROL	Jun 02, 1982	Substantially Equivalent	Syva Co.
K820439	EMIT-AMD AMIKACIN CONTROL	Mar 11, 1982	Substantially Equivalent	Syva Co.
K820392	ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN	Mar 04, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K820323	EMIT AND NETILMICIN CONTROL	Feb 23, 1982	Substantially Equivalent	Syva Co.
K820286	SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL	Feb 23, 1982	Substantially Equivalent	Syva Co.
K820129	ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL	Jan 29, 1982	Substantially Equivalent	Syva Co.
K813241	EMIT-AAD THEOPHYLLINE CONTROL	Dec 03, 1981	Substantially Equivalent	Syva Co.
K812196	EMIT-ST CANNABINOID CONTROLS	Aug 20, 1981	Substantially Equivalent	Syva Co.
K811619	EMIT-ST SERUM PHENOBARBITAL CONTROLS	Jun 25, 1981	Substantially Equivalent	Syva Co.
K811462	EMIT-CAD QUINDINE CONTROL	Jun 09, 1981	Substantially Equivalent	Syva Co.
K810201	TOXICOLOGY CONTROL	Feb 04, 1981	Substantially Equivalent	Utak Laboratories, Inc.
K803107	AMES TDA AMIKACIN CONTROL SERUM	Dec 22, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K801206	EMIT VALPROIC ACID CONTROL	Jun 17, 1980	Substantially Equivalent	Syva Co.
K801205	EMIT DISOPYRAMIDE CONTROL	Jun 09, 1980	Substantially Equivalent	Syva Co.
K800357	BI-LEVEL ASSAYED CARD. DRUG CONT., I,II	Apr 16, 1980	Substantially Equivalent	Ortho Diagnostics, Inc.
K792264	TOBRAMYCIN LIQUID CONTROL SERUM	Dec 18, 1979	Substantially Equivalent	Hemometrix
K792263	TOBRAMYCIN CONTROL SERUM	Dec 18, 1979	Substantially Equivalent	Hemometrix
K792262	GENTAMICIN LIQUID CONTROL SERUM	Dec 18, 1979	Substantially Equivalent	Hemometrix
K792261	GENTAMICIN CONTROL SERUM	Dec 18, 1979	Substantially Equivalent	Hemometrix
K792260	AMIKACIN LIQUID CONTROL SERUM	Dec 18, 1979	Substantially Equivalent	Hemometrix
K792259	AMIKACIN CONTROL SERUM	Dec 18, 1979	Substantially Equivalent	Hemometrix
K790830	EMIT GENTAMICIN CONTROL	May 15, 1979	Substantially Equivalent	Syva Co.
K790402	EMIT-QUINIDINE CONTROL	Mar 15, 1979	Substantially Equivalent	Syva Co.
K782084	EMIT PROCAINAMIDE CONTROL SET	Jan 10, 1979	Substantially Equivalent	Syva Co.
K781827	CONTROL SET, EMIT METHOTREXATE	Jan 03, 1979	Substantially Equivalent	Syva Co.
K780961	THEOPHYLLINE CONTROL SERUM	Dec 07, 1978	Substantially Equivalent	Vitek Systems, Inc.
K780142	ANTICONVULSANT CONTROL SERUM	Feb 03, 1978	Substantially Equivalent	Mcdonnell Douglas Corp.
K760730	ANTICONVULSANT CONTROL SERUM	Oct 07, 1976	Substantially Equivalent	Bio-Reagents & Diagnostics, Inc.