Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3200](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3200) → DKB — Calibrators, Drug Mixture # DKB · Calibrators, Drug Mixture _Clinical Toxicology · 21 CFR 862.3200 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB ## Overview - **Product Code:** DKB - **Device Name:** Calibrators, Drug Mixture - **Regulation:** [21 CFR 862.3200](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3200) - **Device Class:** 2 - **Review Panel:** [Clinical Toxicology](/submissions/TX) ## Identification A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.) ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Recent Cleared Devices (20 of 94) Showing 20 most recent of 94 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K141928](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K141928.md) | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | Roche Diagnostics Operations (Rdo) | Nov 25, 2014 | SESE | | [K133710](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K133710.md) | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | Lin-Zhi International, Inc. | Feb 21, 2014 | SESE | | [K120936](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K120936.md) | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS | Microgenics Corporation | Dec 13, 2012 | SESE | | [K092266](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K092266.md) | RANDOX METHAMPHETAMINE ASSAY | Randox Laboratories, Ltd. | May 9, 2011 | SESE | | [K101752](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K101752.md) | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Microgenics Corp. | Apr 8, 2011 | SESE | | [K090939](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K090939.md) | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 | Roche Diagnostics | Jun 18, 2009 | SESE | | [K090900](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K090900.md) | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 | Siemens Healthcare Diagnostics | Jun 1, 2009 | SESE | | [K062162](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K062162.md) | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) | Dade Behring, Inc. | Sep 14, 2006 | SESE | | [K062121](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K062121.md) | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) | Dade Behring, Inc. | Aug 25, 2006 | SESE | | [K060645](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K060645.md) | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | May 30, 2006 | SESE | | [K051088](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K051088.md) | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Jun 24, 2005 | SESE | | [K033879](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K033879.md) | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | Maine Standards Co. | Feb 27, 2004 | SESE | | [K033306](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K033306.md) | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | Dec 15, 2003 | SESE | | [K032574](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K032574.md) | DIMENSION DRUG CALIBRATOR II, MODEL DC49C | Dade Behring, Inc. | Oct 6, 2003 | SESE | | [K031856](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K031856.md) | PRECISET TDM I AND PRECISET TDM II CALIBRATORS | Roche Diagnostics Corp. | Aug 6, 2003 | SESE | | [K031775](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K031775.md) | PRECISET DAT PLUS I CALIBRATORS | Roche Diagnostics Corp. | Aug 5, 2003 | SESE | | [K021393](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K021393.md) | PRECISET DAT PLUS | Quantimetrix Corp. | Jun 13, 2002 | SESE | | [K013959](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K013959.md) | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS | Bayer Diagnostics Corp. | Jan 29, 2002 | SESE | | [K012318](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K012318.md) | RANDOX THERAPEUTIC DRUG CALIBRATOR | Randox Laboratories, Ltd. | Sep 12, 2001 | SESE | | [K993954](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K993954.md) | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS | Beckman Coulter, Inc. | Jan 11, 2000 | SESE | ## Top Applicants - Syva Co. — 21 clearances - Roche Diagnostic Systems, Inc. — 10 clearances - Diagnostic Reagents, Inc. — 6 clearances - Dade Behring, Inc. — 5 clearances - Microgenics Corp. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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