Product Code: DLJ FDA class 2 21 CFR 862.3200

Calibrators, Drug Specific

Clinical Toxicology

Drug-Specific Calibrators are reference standards used in clinical toxicology laboratories to calibrate analytical instruments and assays measuring specific drugs or drug classes in patient specimens, ensuring result accuracy and traceability. This is a Class 2 device, requiring 510(k) premarket notification before marketing. The product code is DLJ, regulated under 21 CFR 862.3200, within the Clinical Toxicology specialty. No special regulatory flags apply.

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510(k)s

123

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DLJ
Device Class: FDA class 2
Regulation Number: 862.3200
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 123 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K132090	BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2	Aug 08, 2013	Substantially Equivalent	Randox Laboratories, Ltd.
K091617	QMS LIDOCAINE CALIBRATORS, MODEL 0374678	Jul 17, 2009	Substantially Equivalent	Thermo Fisher Scientific
K082030	DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440	Aug 22, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K062182	DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520	Sep 14, 2006	Substantially Equivalent	Dade Behring, Inc.
K062199	DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)	Sep 06, 2006	Substantially Equivalent	Dade Behring, Inc.
K061503	DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)	Jun 22, 2006	Substantially Equivalent	Dade Behring, Inc.
K060503	DIMENSION TACR CALIBRATOR, MODEL DC107	May 18, 2006	Substantially Equivalent	Dade Behring, Inc.
K053108	DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108	Feb 16, 2006	Substantially Equivalent	Dade Behring, Inc.
K052015	DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108	Sep 12, 2005	Substantially Equivalent	Dade Behring, Inc.
K033601	LABONE MICRO-PLATE COTININE EIA	Feb 10, 2004	Substantially Equivalent	Labone, Inc.
K033246	PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS	Dec 02, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K033165	PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS	Oct 14, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K023780	DRI PRIMIDONE CALIBRATORS	Feb 10, 2003	Substantially Equivalent	Microgenics Corp.
K023316	SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS	Dec 16, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K021449	CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS	Jun 18, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K020845	EMIT 2000 VANCOMYCIN CALIBRATORS	May 08, 2002	Substantially Equivalent	Dade Behring, Inc.
K020769	SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS	Apr 03, 2002	Substantially Equivalent	Lin-Zhi International, Inc.
K012109	DRI ECSTASY URINE CALIBRATORS	Aug 27, 2001	Substantially Equivalent	Microgenics Corp.
K011112	CYCLOSPORINE CALIBRATOR	Jul 17, 2001	Substantially Equivalent	Dade Behring, Inc.
K993473	SYNCHRON SYSTEMS DRUG CALIBRATOR 2	Nov 26, 1999	Substantially Equivalent	Beckman Coulter, Inc.
K993022	SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS	Nov 09, 1999	Substantially Equivalent	Beckman Coulter, Inc.
K983556	ABUSCREEN ONLINE BENZ 300 CALIBRATORS	Dec 15, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K983555	ABUSCREEN ONLINE BENZ 200 CALIBRATORS	Dec 15, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K981926	ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS	Jul 22, 1998	Substantially Equivalent	Emd Chemicals, Inc.
K973536	ACE PHENOBARBITAL REAGENT/AED CALIBRATORS	Nov 06, 1997	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K972835	50NG/ML COCAINE METABOLITE CALIBRATOR	Aug 28, 1997	Substantially Equivalent	Diagnostic Reagents, Inc.
K972433	CEDIA DIGOXIN CALIBRATORS	Jul 24, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K970509	INNOFLOUR CALIBRATOR REAGENT SET	May 12, 1997	Substantially Equivalent	Oxis Intl., Inc.
K962280	ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR	Aug 16, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K961726	ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20	Jul 11, 1996	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K940048	STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION	Mar 19, 1996	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K955813	CEDIA DAU LSD CALBIRATORS	Feb 09, 1996	Substantially Equivalent	Microgenics Corp.
K951153	CEDIA DAU PPX/METH CALIBRATOR	Apr 21, 1995	Substantially Equivalent	Microgenics Corp.
K945338	THEOPHYLLINE CALIBRATORS	Jan 17, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K945316	PHENOBARBITAL CALIBRATORS	Jan 04, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K945337	PHENYTOIN CALIBRATORS	Dec 07, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K935795	CEDIA DAU THC CALIBRATORS	Apr 06, 1994	Substantially Equivalent	Microgenics Corp.
K932548	ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS	Dec 29, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K934144	DUPONT ACA URINE METHADONE CALIBRATOR	Nov 09, 1993	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K933279	ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR	Aug 09, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K931506	URINE CALIBRATOR AND CONTROL	Jul 28, 1993	Substantially Equivalent	Diagnostic Reagents, Inc.
K923386	THC URINE CALIBRATORS	Sep 14, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K920749	THC URINE CALIBRATORS	Mar 18, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K915464	DIGITOXIN FPIA CALIBRATOR SET	Jan 15, 1992	Substantially Equivalent	Sigma Diagnostics, Inc.
K913186	INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET	Aug 30, 1991	Substantially Equivalent	Intl. Bioclinical, Inc.
K912048	ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS	Jul 26, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K911466	INNOFLUOR VALPROIC ACID CALIBRATOR SET	May 23, 1991	Substantially Equivalent	Intl. Bioclinical, Inc.
K910086	ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS	Jan 17, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K904569	EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS	Dec 26, 1990	Substantially Equivalent	Syva Co.
K904307	DUPONT SALICYLATE CALIBRATOR	Nov 06, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K904303	DUPONT DRUG CLIBRATOR-B	Oct 26, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K904308	DUPONT ALCOHOL CALIBRATOR	Oct 12, 1990	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K903101	INNOFLUOR (TM) AMIKACIN CALIBRATOR SET	Aug 22, 1990	Substantially Equivalent	Innotron of Oregon, Inc.
K895826	INNOFLUOR DIGOXIN CALIBRATOR SET	Oct 30, 1989	Substantially Equivalent	Innotron of Oregon, Inc.
K895572	N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT	Oct 30, 1989	Substantially Equivalent	Tudor Laboratories, Inc.
K895570	VALPROIC ACID (FPIA) CALIBRATOR KIT	Sep 28, 1989	Substantially Equivalent	Tudor Laboratories, Inc.
K895568	PRIMIDONE (FPIA) CALIBRATOR KIT	Sep 28, 1989	Substantially Equivalent	Tudor Laboratories, Inc.
K894522	FPR DIGOXIN CALIBRATOR KIT	Sep 25, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K894530	FPR THEOPHYLLINE CALIBRATOR KIT	Sep 18, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K894532	FPR TOBRAMYCIN CALIBRATOR KIT	Sep 01, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K894526	FPR PHENOBARBITAL CALIBRATOR KIT	Aug 28, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K894520	FPR CARBAMAZEPINE CALIBRATOR KIT	Aug 28, 1989	Substantially Equivalent	Colony Laboratories, Inc.
K893506	INNOFLUOR CARBAMAZEPINE CALIBRATOR SET	Aug 15, 1989	Substantially Equivalent	Innotron of Oregon, Inc.
K892212	INNOFLUOR(TM) QUINDINE CALIBATOR SET	Jun 09, 1989	Substantially Equivalent	Innotron of Oregon, Inc.
K892901	ACA VANCOMYCIN CALIBRATOR	May 16, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K890452	EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR	Feb 10, 1989	Substantially Equivalent	Syva Co.
K890451	EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR	Feb 10, 1989	Substantially Equivalent	Syva Co.
K884745	DU PONT ACA METHOTREXATE CALIBRATOR	Jan 30, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K884170	ANALYST THEOPHYLLINE CALIBRATOR	Nov 16, 1988	Substantially Equivalent	The DU Pont Co.
K883920	EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A	Oct 11, 1988	Substantially Equivalent	Syva Co.
K881337	EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95	May 27, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K875135	EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL	Apr 05, 1988	Substantially Equivalent	Syva Co.
K874101	EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95	Nov 09, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K874102	EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95	Nov 05, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K873436	EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95	Oct 29, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K873281	CARBAMAZEPINE (FPIA) CALIBRATOR KIT	Oct 28, 1987	Substantially Equivalent	Windsor Laboratories, Inc.
K872644	INNOFLUOR VANCOMYCIN CALIBRATOR SET	Jul 21, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K872463	INNOFLUOR(TM) THEOPHYLLINE CALIBRATOR SET	Jul 21, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K872462	INNOFLUOR(TM) GENTAMICIN CALIBRATOR SET	Jul 21, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K872461	INNOFLUOR(TM) PHENOBARBITAL CALIBRATOR SET	Jul 21, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K872349	INNOFLUOR (TM) TOBRAMYCIN CALIBRATOR SET	Jul 21, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K872181	ETHANOL CALIBRATOR	Jul 21, 1987	Substantially Equivalent	American Monitor Corp.
K872142	INNOFLUOR PHENYTOIN CALIBRATOR SET	Jul 21, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K872328	DIGOXIN FPIA CALIBRATORS	Jul 07, 1987	Substantially Equivalent	Sigma Chemical Co.
K871423	PHENYTOIN FPIA CALIBRATORS	Jun 11, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K871394	THEOPHYLLINE FPIA CALIBRATORS	Jun 01, 1987	Substantially Equivalent	Sigma Diagnostics, Inc.
K871330	EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95	Apr 22, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K870390	PHENOBARBITAL (FPIA) CALIBRATOR KIT	Apr 01, 1987	Substantially Equivalent	Windsor Laboratories, Inc.
K870389	DIGOXIN (FPIA) CALIBRATOR KIT	Apr 01, 1987	Substantially Equivalent	Windsor Laboratories, Inc.
K870247	EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93	Feb 11, 1987	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863244	AMIKACIN (FPIA) CALIBRATOR KIT	Aug 29, 1986	Substantially Equivalent	Windsor Laboratories, Inc.
K862964	ANTIASTHMATIC CALIBRATORS	Aug 19, 1986	Substantially Equivalent	American Monitor Corp.
K861395	EMIT COLUMN DIGOXIN CALIBRATORS	May 07, 1986	Substantially Equivalent	Syva Co.
K850457	DU PONT DIGOXIN ASSAY CALIBRATOR	Mar 05, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K850059	DU PONT GENTAMICIN ASSAY CALIBRATOR	Jan 18, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K850057	DU PONT TOBRAMYCIN ASSAY CALIBRATOR	Jan 18, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K843420	EMIT 700 CANNABINOID CALIBRATOR	Sep 26, 1984	Substantially Equivalent	Syva Co.
K843210	AMIKACIN CALIBRATOR ACA	Sep 14, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K834457	EMIT D.A.U. URINE CANNABINOID CALIBRA	Jun 22, 1984	Substantially Equivalent	Syva Co.
K841655	DUPONT THEOPHYLLINE DIT CALIBRATOR	May 16, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K841108	ACA DIGOXIN CALLIBRATOR	Apr 19, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K840597	QUINIDINE CALIBRATOR	Mar 23, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K833977	SERALYZER DRUG ASSAY CONTROL SERUM	Mar 19, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K833383	PROCAINAMIDE CALIBRATOR	Dec 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K833382	VALPROIC ACID CALIBRATOR	Dec 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K833380	LIDOAINE CALIBRATOR	Dec 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832982	ACA TOBRAMYCIN CALIBRATOR	Oct 27, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K831980	EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA	Jul 19, 1983	Substantially Equivalent	Syva Co.
K831933	THEOPHYLLINE ACA CALIBRATOR	Jul 19, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K831209	GENTAMICIN CALIBRATOR -ACA	May 16, 1983	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K822587	ADVANCE EMIT-CAD QUINIDINE CONTROL	Sep 21, 1982	Substantially Equivalent	Syva Co.
K822052	EMIT D.A.V. METHAQUALONE URINE CALIBRA	Jul 27, 1982	Substantially Equivalent	Syva Co.
K812197	EMIT-ST CANNABINOID CALIBRATOR	Aug 20, 1981	Substantially Equivalent	Syva Co.
K811622	EMIT-ST SERUM PHENOBARBITAL CALIBRATOR	Jun 25, 1981	Substantially Equivalent	Syva Co.
K800247	EMIT -D.A.U. CANNABINOID URINE CALIBS.	Feb 26, 1980	Substantially Equivalent	Syva Co.
K790399	URINE MEDIUM CALIBRATOR	Jun 15, 1979	Substantially Equivalent	Syva Co.
K790398	EMIT-D.A.U. PHENCYCLIDINE URINE LOW	Jun 15, 1979	Substantially Equivalent	Syva Co.
K780731	LIDOCAINE CALIBRATOR KIT	Jan 17, 1979	Substantially Equivalent	Vitek Systems, Inc.
K780732	PROCAINAMIDE CALIBRATOR KIT	Nov 22, 1978	Substantially Equivalent	Vitek Systems, Inc.
K772167	EMIT LIDOCAINE CONTROL	Nov 22, 1977	Substantially Equivalent	Syva Co.
K772166	EMIT THEOPHYLLINE CONTROL	Nov 22, 1977	Substantially Equivalent	Syva Co.
K771805	ACA SALICYLATE CALIBRATOR	Oct 04, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K771799	ACA ALCOHOL CALIBRATORS	Oct 04, 1977	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.