Calibrators, Drug Mixture
FDA product code DKB · Class II (moderate risk) · 21 CFR 862.3200 · Clinical Toxicology
94510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Syva Co. 21
- Roche Diagnostic Systems, Inc. 10
- Microgenics Corp. 6
- Diagnostic Reagents, Inc. 6
- Dade Behring, Inc. 5
- Roche Diagnostics Corp. 5
- Hycor Biomedical, Inc. 3
- E.I. Dupont DE Nemours & Co., Inc. 3
- Instrumentation Laboratory CO 3
- Boehringer Mannheim Corp. 3
- Beckman Coulter Inc. 3
- Supelco, Inc. 3
- Verichem Laboratories, Inc. 2
- Lin-Zhi International, Inc. 2
- Randox Laboratories, Ltd. 2
- Beckman Instruments, Inc. 2
- Gelman Sciences, Inc. 1
- Biodiagnostic Intl 1
- Roche Diagnostics Operations (Rdo) 1
- Medi-Tech, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141928 | Cobas C Acetaminophen GEN.2 Assay, ACET2 CalibratorDKB · Traditional | Roche Diagnostics Operations (Rdo) | 11/25/2014SE |
| K133710 | Lzi Multiple Analyte Set A;B;C Drugs of Abuse ControlsDKB · Traditional | Lin-Zhi International, Inc. | 02/21/2014SE |
| K120936 | Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent…DKB · Abbreviated | Microgenics Corporation | 12/13/2012SE |
| K092266 | Randox Methamphetamine AssayDKB · Traditional | Randox Laboratories, Ltd. | 05/09/2011SE |
| K101752 | Thermo Scientific Cedia Multi-Drug Oft CalibratorsDKB · Traditional | Microgenics Corp. | 04/08/2011SE |
| K090939 | Roche C.F.A.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…DKB · Traditional | Roche Diagnostics | 06/18/2009SE |
| K090900 | Advia Chemistry Drug Calibrator II, Model 10376771DKB · Abbreviated | Siemens Healthcare Diagnostics | 06/01/2009SE |
| K062162 | Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)DKB · Traditional | Dade Behring, Inc. | 09/14/2006SE |
| K062121 | Dimension Vista System Drug 2 Calibrator (Drug 2 Cal - KC420)DKB · Traditional | Dade Behring, Inc. | 08/25/2006SE |
| K060645 | Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsDKB · Abbreviated | Roche Diagnostics Corp. | 05/30/2006SE |
| K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsDKB · Traditional | Lin-Zhi International, Inc. | 06/24/2005SE |
| K033879 | Validate TDM Calibration Verification Test Set, Model 126DKB · Traditional | Maine Standards Co. | 02/27/2004SE |
| K033306 | Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsDKB · Abbreviated | Roche Diagnostics Corp. | 12/15/2003SE |
| K032574 | Dimension Drug Calibrator II, Model DC49CDKB · Traditional | Dade Behring, Inc. | 10/06/2003SE |
| K031856 | Preciset TDM I and Preciset TDM II CalibratorsDKB · Abbreviated | Roche Diagnostics Corp. | 08/06/2003SE |
| K031775 | Preciset Dat Plus I CalibratorsDKB · Abbreviated | Roche Diagnostics Corp. | 08/05/2003SE |
| K021393 | Preciset Dat PlusDKB · Traditional | Quantimetrix Corp. | 06/13/2002SE |
| K013959 | Bayer Valproic Acid Assay for the ACS:180 and Advia Centaur AnalyzersDKB · Traditional | Bayer Diagnostics Corp. | 01/29/2002SE |
| K012318 | Randox Therapeutic Drug CalibratorDKB · Traditional | Randox Laboratories, Ltd. | 09/12/2001SE |
| K993954 | Synchron Systems Dat Multi-Drug Low and High Urine CalibratorsDKB · Traditional | Beckman Coulter, Inc. | 01/11/2000SE |
| K993755 | Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5DKB · Abbreviated | Syva Co. | 12/21/1999SE |
| K990255 | Dimension Drug Calibrator II, Model DC49BDKB · Traditional | Dade Behring, Inc. | 02/16/1999SE |
| K983747 | Synchron Systems Dat Low and High Urine Calibrators IIDKB · Traditional | Beckman Coulter, Inc. | 12/30/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | Diagnostic Reagents, Inc. | 11/05/1998SE |
| K983209 | Synchron Systems Dat Low and High Urine Calibrators IDKB · Traditional | Beckman Coulter, Inc. | 11/04/1998SE |
| K982871 | Drug Calibrator IIDKB · Traditional | Dade Behring, Inc. | 10/13/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | Beckman Instruments, Inc. | 05/08/1998SE |
| K980853 | Cedia Dau Multi-Drug CalibratorsDKB · Traditional | Boehringer Mannheim Corp. | 04/21/1998SE |
| K974699 | Reference Material for Amphetamine/Methamphetamine in Human UrineDKB · Traditional | Consolidated Technologies, Inc. | 01/22/1998SE |
| K971600 | Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)DKB · Traditional | Behring Diagnostics, Inc. | 06/25/1997SE |
| K971287 | Synchron Systems Drug Calibration 3 PlusDKB · Traditional | Beckman Instruments, Inc. | 05/08/1997SE |
| K962817 | Drug Calibrator IIDKB · Traditional | Dade Intl., Inc. | 09/16/1996SE |
| K963191 | Cedia Antibiotic TDM Multi-CalsDKB · Traditional | Boehringer Mannheim Corp. | 09/10/1996SE |
| K961273 | AED CalibratorsDKB · Traditional | Diagnostic Reagents, Inc. | 05/15/1996SE |
| K961372 | Serum Tox CalibratorDKB · Traditional | Diagnostic Reagents, Inc. | 05/01/1996SE |
| K954608 | Cedia Dau Multi-Dr Calibrator/Pri, Sec, Inter, HighDKB · Traditional | Boehringer Mannheim Corp. | 12/26/1995SE |
| K935192 | Emit Iic CalibratorsDKB · Traditional | Syva Co. | 03/24/1995SE |
| K950139 | Drugs of Abuse CalibratorDKB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 02/22/1995SE |
| K945289 | Doa - Immunoassay Cut-Off CalibratorDKB · Traditional | Medi-Tech, Inc. | 12/13/1994SE |
| K942048 | Roche Ammonia (Various)DKB · Traditional | Roche Diagnostic Systems, Inc. | 10/04/1994SE |
| K940935 | Urine CalibratorDKB · Traditional | Diagnostic Reagents, Inc. | 07/06/1994SE |
| K936028 | Cedia(R) Dau Bar/Benz 300,300 Intermed & High CalibDKB · Traditional | Microgenics Corp. | 03/14/1994SE |
| K935793 | Cedia Dau Negative CalibratorDKB · Traditional | Microgenics Corp. | 03/14/1994SE |
| K935101 | Urine Calibrators and Controls ModificationDKB · Traditional | Diagnostic Reagents, Inc. | 01/27/1994SE |
| K935794 | Cedia Dau 4-DRUG Cutoff CalibratorDKB · Traditional | Microgenics Corp. | 01/25/1994SE |
| K935792 | Cedia Dau 5-DRUG CalibratorsDKB · Traditional | Microgenics Corp. | 01/25/1994SE |
| K935550 | Abuscreen Online Negative Cal/Control Cal Pack and Mil Calibration PackDKB · Traditional | Roche Diagnostic Systems, Inc. | 01/03/1994SE |
| K931124 | Abuscreen Online(R) CalibratorsDKB · Traditional | Roche Diagnostic Systems, Inc. | 08/03/1993SE |
| K932754 | Abuscreen Calibration StandardDKB · Traditional | Roche Diagnostic Systems, Inc. | 07/22/1993SE |
| K932753 | Roche Abuscreen Tri-Level Reference ControlsDKB · Traditional | Roche Diagnostic Systems, Inc. | 07/22/1993SE |
| K923340 | Roche Abuscreen Onlinne CalibratorsDKB · Traditional | Roche Diagnostic Systems, Inc. | 08/04/1992SE |
| K920208 | Urine a CalibratorDKB · Traditional | Diagnostic Reagents, Inc. | 03/04/1992SE |
| K915003 | Emit Calibrator Level 1(CUTOFF)/LEVEL 2(HIGH)DKB · Traditional | Syva Co. | 11/29/1991SE |
| K913741 | Il Test(Tm) Dat Cal/Control Set CDKB · Traditional | Instrumentation Laboratory CO | 10/21/1991SE |
| K913740 | Il Test(Tm) Dat Cal/Control Set BDKB · Traditional | Instrumentation Laboratory CO | 10/21/1991SE |
| K910881 | Control and LinearityDKB · Traditional | Gds Diagnostics | 09/13/1991SE |
| K913739 | Il Test(Tm) Dat Calibrator a( -)DKB · Traditional | Instrumentation Laboratory CO | 09/10/1991SE |
| K913335 | Abuscreen(R) Online(Tm) CalibratorsDKB · Traditional | Roche Diagnostic Systems, Inc. | 08/26/1991SE |
| K912729 | Emit Calibrator B Level 1(CUTOFF) & Level 2(HIGH)DKB · Traditional | Syva Co. | 07/22/1991SE |
| K910085 | Abuscreen Online Cannabinoids CalibratorsDKB · Traditional | Roche Diagnostic Systems, Inc. | 03/11/1991SE |
| K910087 | Abuscreen Online Opiates CalibratorsDKB · Traditional | Roche Diagnostic Systems, Inc. | 02/04/1991SE |
| K905828 | Abuscreen(R) Online CalibratorsDKB · Traditional | Roche Diagnostic Systems, Inc. | 02/04/1991SE |
| K904764 | Emit (R) II Calibrator a Level 1 (Cutoff) 2 (High)DKB · Traditional | Syva Co. | 11/20/1990SE |
| K903152 | Emit Ethyl Alcohol Calibrators and ControlsDKB · Traditional | Syva Co. | 08/17/1990SE |
| K902581 | Emit(R) II Calibrator Level 0 (Negative)DKB · Traditional | Syva Co. | 07/27/1990SE |
| K902578 | Emit(R) II Calibrator a Level 1 & Level 2DKB · Traditional | Syva Co. | 07/10/1990SE |
| K901573 | Emit D.A.U. Low and Medium Calibrators BDKB · Traditional | Syva Co. | 06/06/1990SE |
| K894934 | Hycor Sentry Drugs of Abuse Urine CalibratorsDKB · Traditional | Hycor Biomedical, Inc. | 10/17/1989SE |
| K893815 | Hycor Sentry(Tm) Drugs of Abuse Urine CalibratorsDKB · Traditional | Hycor Biomedical, Inc. | 07/25/1989SE |
| K892332 | Drugs of Abuse Urine CalibratorsDKB · Traditional | Hycor Biomedical, Inc. | 05/11/1989SE |
| K884177 | Drug Standard SetDKB · Traditional | Gelman Sciences, Inc. | 02/17/1989SE |
| K881320 | Urine Toxicology StandardDKB · Traditional | Verichem Laboratories, Inc. | 09/09/1988SE |
| K881943 | Emit Hva Calibrator KitDKB · Traditional | Syva Co. | 07/08/1988SE |
| K875216 | High Performance CalibratorsDKB · Traditional | Rapid Diagnostic Laboratories, Inc. | 06/22/1988SE |
| K880705 | Therapeutic Drug StandardDKB · Traditional | Verichem Laboratories, Inc. | 05/31/1988SE |
| K872392 | Aca Urine Drugs of Abuse CalibratorDKB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/14/1987SE |
| K871174 | 4-9295 Barbiturates Test MixDKB · Traditional | Supelco, Inc. | 06/11/1987SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | Diagnostic Systems | 07/11/1986SE |
| K843507 | Emit 700 Calibrator BDKB · Traditional | Syva Co. | 09/26/1984SE |
| K843163 | Emit 700 Calibrator aDKB · Traditional | Syva Co. | 09/12/1984SE |
| K842816 | Emit D.A.U. Low & Med. Calibrators BDKB · Traditional | Syva Co. | 09/05/1984SE |
| K842386 | Aca Barbiturates Screen/BenzodiazepinDKB · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/15/1984SE |
| K834398 | Liqui-Sera TDM CalibratorsDKB · Traditional | Biodiagnostic Intl | 02/03/1984SE |
| K833761 | Therapeutic Drug ControlDKB · Traditional | Icl Scientific | 01/13/1984SE |
| K833276 | Drug StandardsDKB · Traditional | Supelco, Inc. | 01/01/1984SE |
| K823740 | Advance System Emitaed AntiepilepticDKB · Traditional | Syva Co. | 01/05/1983SE |
| K821767 | Emit ST Urine Methagualone CalibratorDKB · Traditional | Syva Co. | 06/25/1982SE |
| K820461 | Emit-St Urine Calibrator a (#3A319DKB · Traditional | Syva Co. | 03/11/1982SE |
| K820190 | Calibrator SetDKB · Traditional | Syva Co. | 02/12/1982SE |
| K811674 | Drug StandardsDKB · Traditional | Supelco, Inc. | 07/15/1981SE |
| K811620 | Emit-Tox Serum CalibratorsDKB · Traditional | Syva Co. | 06/25/1981SE |
| K810464 | Emit-St Serum CalbratorDKB · Traditional | Syva Co. | 03/06/1981SE |
| K802624 | Emit-Stm Urine CalibratorsDKB · Traditional | Syva Co. | 11/12/1980SE |
| K790735 | Emit-Tox Serum CalibratorsDKB · Traditional | Syva Co. | 05/03/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0220-2023 Class II | VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro…Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for… | Ortho-Clinical Diagnostics, Inc. | 10/13/2022Open, Classified |
| Z-0933-2022 Class II | Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing…The product was stored incorrectly due to improper storage controls which may lead to delayed results. | MEDLINE INDUSTRIES, LP - Northfield | 03/08/2022Terminated |
| Z-1805-2014 Class II | VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 --…Calibrator values assigned for the calibrator kit lots were released using a reference method that was… | Ortho-Clinical Diagnostics | 05/12/2014Terminated |
| Z-0665-2013 Class III | Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM)…Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct… | Siemens Healthcare Diagnostics, Inc. | 12/06/2012Terminated |
| Z-0847-2012 | Multi-Analyte Urine DAU Calibrator (15 mL); Multi-Analyte,Intermediate Calibrator; for…Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly… | Lin-Zhi International Inc | 10/11/2011Terminated |
| Z-0868-2012 | Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in…Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO… | Lin-Zhi International Inc | 08/23/2011Terminated |
| Z-1174-2012 | Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT.…The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the… | Beckman Coulter Inc. | 08/11/2009Terminated |
| Z-2001-2009 | Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781…The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the… | Roche Diagnostics Corp. | 04/22/2009Terminated |
| Z-2000-2009 | Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790…The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the… | Roche Diagnostics Corp. | 04/22/2009Terminated |