Product Code: DKB FDA class 2 21 CFR 862.3200

Calibrators, Drug Mixture

Clinical Toxicology

The Drug Mixture Calibrators are reference standards containing known concentrations of multiple drug analytes used to calibrate quantitative drug testing instruments and assays in clinical toxicology laboratories. This device is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3200 within the Clinical Toxicology specialty. No special risk flags are associated with this product.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DKB
Device Class: FDA class 2
Regulation Number: 862.3200
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 94 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K141928	COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR	Nov 25, 2014	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K133710	LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS	Feb 21, 2014	Substantially Equivalent	Lin-Zhi International, Inc.
K120936	ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS	Dec 13, 2012	Substantially Equivalent	Microgenics Corporation
K092266	RANDOX METHAMPHETAMINE ASSAY	May 09, 2011	Substantially Equivalent	Randox Laboratories, Ltd.
K101752	THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS	Apr 08, 2011	Substantially Equivalent	Microgenics Corp.
K090939	ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190	Jun 18, 2009	Substantially Equivalent	Roche Diagnostics
K090900	ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771	Jun 01, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K062162	DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)	Sep 14, 2006	Substantially Equivalent	Dade Behring, Inc.
K062121	DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)	Aug 25, 2006	Substantially Equivalent	Dade Behring, Inc.
K060645	PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS	May 30, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K051088	MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS	Jun 24, 2005	Substantially Equivalent	Lin-Zhi International, Inc.
K033879	VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126	Feb 27, 2004	Substantially Equivalent	Maine Standards Co.
K033306	PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS	Dec 15, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K032574	DIMENSION DRUG CALIBRATOR II, MODEL DC49C	Oct 06, 2003	Substantially Equivalent	Dade Behring, Inc.
K031856	PRECISET TDM I AND PRECISET TDM II CALIBRATORS	Aug 06, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K031775	PRECISET DAT PLUS I CALIBRATORS	Aug 05, 2003	Substantially Equivalent	Roche Diagnostics Corp.
K021393	PRECISET DAT PLUS	Jun 13, 2002	Substantially Equivalent	Quantimetrix Corp.
K013959	BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS	Jan 29, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K012318	RANDOX THERAPEUTIC DRUG CALIBRATOR	Sep 12, 2001	Substantially Equivalent	Randox Laboratories, Ltd.
K993954	SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS	Jan 11, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K993755	EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5	Dec 21, 1999	Substantially Equivalent	Syva Co.
K990255	DIMENSION DRUG CALIBRATOR II, MODEL DC49B	Feb 16, 1999	Substantially Equivalent	Dade Behring, Inc.
K983747	SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II	Dec 30, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K983159	DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS	Nov 05, 1998	Substantially Equivalent	Diagnostic Reagents, Inc.
K983209	SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I	Nov 04, 1998	Substantially Equivalent	Beckman Coulter, Inc.
K982871	DRUG CALIBRATOR II	Oct 13, 1998	Substantially Equivalent	Dade Behring, Inc.
K981403	IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT	May 08, 1998	Substantially Equivalent	Beckman Instruments, Inc.
K980853	CEDIA DAU MULTI-DRUG CALIBRATORS	Apr 21, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K974699	REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE	Jan 22, 1998	Substantially Equivalent	Consolidated Technologies, Inc.
K971600	EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)	Jun 25, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K971287	SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS	May 08, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K962817	DRUG CALIBRATOR II	Sep 16, 1996	Substantially Equivalent	Dade Intl., Inc.
K963191	CEDIA ANTIBIOTIC TDM MULTI-CALS	Sep 10, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K961273	AED CALIBRATORS	May 15, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K961372	SERUM TOX CALIBRATOR	May 01, 1996	Substantially Equivalent	Diagnostic Reagents, Inc.
K954608	CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH	Dec 26, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K935192	EMIT IIC CALIBRATORS	Mar 24, 1995	Substantially Equivalent	Syva Co.
K950139	DRUGS OF ABUSE CALIBRATOR	Feb 22, 1995	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K945289	DOA - IMMUNOASSAY CUT-OFF CALIBRATOR	Dec 13, 1994	Substantially Equivalent	Medi-Tech, Inc.
K942048	ROCHE AMMONIA (VARIOUS)	Oct 04, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K940935	URINE CALIBRATOR	Jul 06, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K936028	CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB	Mar 14, 1994	Substantially Equivalent	Microgenics Corp.
K935793	CEDIA DAU NEGATIVE CALIBRATOR	Mar 14, 1994	Substantially Equivalent	Microgenics Corp.
K935101	URINE CALIBRATORS AND CONTROLS MODIFICATION	Jan 27, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K935794	CEDIA DAU 4-DRUG CUTOFF CALIBRATOR	Jan 25, 1994	Substantially Equivalent	Microgenics Corp.
K935792	CEDIA DAU 5-DRUG CALIBRATORS	Jan 25, 1994	Substantially Equivalent	Microgenics Corp.
K935550	ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK	Jan 03, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K931124	ABUSCREEN ONLINE(R) CALIBRATORS	Aug 03, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K932754	ABUSCREEN CALIBRATION STANDARD	Jul 22, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K932753	ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS	Jul 22, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K923340	ROCHE ABUSCREEN ONLINNE CALIBRATORS	Aug 04, 1992	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K920208	URINE A CALIBRATOR	Mar 04, 1992	Substantially Equivalent	Diagnostic Reagents, Inc.
K915003	EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)	Nov 29, 1991	Substantially Equivalent	Syva Co.
K913741	IL TEST(TM) DAT CAL/CONTROL SET C	Oct 21, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K913740	IL TEST(TM) DAT CAL/CONTROL SET B	Oct 21, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K910881	CONTROL AND LINEARITY	Sep 13, 1991	Substantially Equivalent	Gds Diagnostics
K913739	IL TEST(TM) DAT CALIBRATOR A( -)	Sep 10, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K913335	ABUSCREEN(R) ONLINE(TM) CALIBRATORS	Aug 26, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K912729	EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)	Jul 22, 1991	Substantially Equivalent	Syva Co.
K910085	ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS	Mar 11, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K910087	ABUSCREEN ONLINE OPIATES CALIBRATORS	Feb 04, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K905828	ABUSCREEN(R) ONLINE CALIBRATORS	Feb 04, 1991	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K904764	EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)	Nov 20, 1990	Substantially Equivalent	Syva Co.
K903152	EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS	Aug 17, 1990	Substantially Equivalent	Syva Co.
K902581	EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)	Jul 27, 1990	Substantially Equivalent	Syva Co.
K902578	EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2	Jul 10, 1990	Substantially Equivalent	Syva Co.
K901573	EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B	Jun 06, 1990	Substantially Equivalent	Syva Co.
K894934	HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS	Oct 17, 1989	Substantially Equivalent	Hycor Biomedical, Inc.
K893815	HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS	Jul 25, 1989	Substantially Equivalent	Hycor Biomedical, Inc.
K892332	DRUGS OF ABUSE URINE CALIBRATORS	May 11, 1989	Substantially Equivalent	Hycor Biomedical, Inc.
K884177	DRUG STANDARD SET	Feb 17, 1989	Substantially Equivalent	Gelman Sciences, Inc.
K881320	URINE TOXICOLOGY STANDARD	Sep 09, 1988	Substantially Equivalent	Verichem Laboratories, Inc.
K881943	EMIT HVA CALIBRATOR KIT	Jul 08, 1988	Substantially Equivalent	Syva Co.
K875216	HIGH PERFORMANCE CALIBRATORS	Jun 22, 1988	Substantially Equivalent	Rapid Diagnostic Laboratories, Inc.
K880705	THERAPEUTIC DRUG STANDARD	May 31, 1988	Substantially Equivalent	Verichem Laboratories, Inc.
K872392	ACA URINE DRUGS OF ABUSE CALIBRATOR	Sep 14, 1987	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K871174	4-9295 BARBITURATES TEST MIX	Jun 11, 1987	Substantially Equivalent	Supelco, Inc.
K862403	EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95	Jul 11, 1986	Substantially Equivalent	Diagnostic Systems
K843507	EMIT 700 CALIBRATOR B	Sep 26, 1984	Substantially Equivalent	Syva Co.
K843163	EMIT 700 CALIBRATOR A	Sep 12, 1984	Substantially Equivalent	Syva Co.
K842816	EMIT D.A.U. LOW & MED. CALIBRATORS B	Sep 05, 1984	Substantially Equivalent	Syva Co.
K842386	ACA BARBITURATES SCREEN/BENZODIAZEPIN	Aug 15, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K834398	LIQUI-SERA TDM CALIBRATORS	Feb 03, 1984	Substantially Equivalent	Biodiagnostic Intl
K833761	THERAPEUTIC DRUG CONTROL	Jan 13, 1984	Substantially Equivalent	Icl Scientific
K833276	DRUG STANDARDS	Jan 01, 1984	Substantially Equivalent	Supelco, Inc.
K823740	ADVANCE SYSTEM EMITAED ANTIEPILEPTIC	Jan 05, 1983	Substantially Equivalent	Syva Co.
K821767	EMIT ST URINE METHAGUALONE CALIBRATOR	Jun 25, 1982	Substantially Equivalent	Syva Co.
K820461	EMIT-ST URINE CALIBRATOR A (#3A319	Mar 11, 1982	Substantially Equivalent	Syva Co.
K820190	CALIBRATOR SET	Feb 12, 1982	Substantially Equivalent	Syva Co.
K811674	DRUG STANDARDS	Jul 15, 1981	Substantially Equivalent	Supelco, Inc.
K811620	EMIT-TOX SERUM CALIBRATORS	Jun 25, 1981	Substantially Equivalent	Syva Co.
K810464	EMIT-ST SERUM CALBRATOR	Mar 06, 1981	Substantially Equivalent	Syva Co.
K802624	EMIT-STM URINE CALIBRATORS	Nov 12, 1980	Substantially Equivalent	Syva Co.
K790735	EMIT-TOX SERUM CALIBRATORS	May 03, 1979	Substantially Equivalent	Syva Co.