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) → DLJ — Calibrators, Drug Specific # DLJ · Calibrators, Drug Specific _Clinical Toxicology · 21 CFR 862.3200 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ ## Overview - **Product Code:** DLJ - **Device Name:** Calibrators, Drug Specific - **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 123) Showing 20 most recent of 123 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K132090](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K132090.md) | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | Randox Laboratories, Ltd. | Aug 8, 2013 | SESE | | [K091617](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K091617.md) | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | Thermo Fisher Scientific | Jul 17, 2009 | SESE | | [K082030](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K082030.md) | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 | Siemens Healthcare Diagnostics, Inc. | Aug 22, 2008 | SESE | | [K062182](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K062182.md) | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | Dade Behring, Inc. | Sep 14, 2006 | SESE | | [K062199](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K062199.md) | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) | Dade Behring, Inc. | Sep 6, 2006 | SESE | | [K061503](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K061503.md) | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) | Dade Behring, Inc. | Jun 22, 2006 | SESE | | [K060503](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K060503.md) | DIMENSION TACR CALIBRATOR, MODEL DC107 | Dade Behring, Inc. | May 18, 2006 | SESE | | [K053108](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K053108.md) | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 | Dade Behring, Inc. | Feb 16, 2006 | SESE | | [K052015](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K052015.md) | DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 | Dade Behring, Inc. | Sep 12, 2005 | SESE | | [K033601](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K033601.md) | LABONE MICRO-PLATE COTININE EIA | Labone, Inc. | Feb 10, 2004 | SESE | | [K033246](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K033246.md) | PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS | Roche Diagnostics Corp. | Dec 2, 2003 | SESE | | [K033165](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K033165.md) | PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS | Roche Diagnostics Corp. | Oct 14, 2003 | SESE | | [K023780](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K023780.md) | DRI PRIMIDONE CALIBRATORS | Microgenics Corp. | Feb 10, 2003 | SESE | | [K023316](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K023316.md) | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Dec 16, 2002 | SESE | | [K021449](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K021449.md) | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Jun 18, 2002 | SESE | | [K020845](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K020845.md) | EMIT 2000 VANCOMYCIN CALIBRATORS | Dade Behring, Inc. | May 8, 2002 | SESE | | [K020769](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K020769.md) | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Apr 3, 2002 | SESE | | [K012109](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K012109.md) | DRI ECSTASY URINE CALIBRATORS | Microgenics Corp. | Aug 27, 2001 | SESE | | [K011112](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K011112.md) | CYCLOSPORINE CALIBRATOR | Dade Behring, Inc. | Jul 17, 2001 | SESE | | [K993473](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K993473.md) | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 | Beckman Coulter, Inc. | Nov 26, 1999 | SESE | ## Top Applicants - E.I. Dupont DE Nemours & Co., Inc. — 21 clearances - Syva Co. — 18 clearances - Innotron of Oregon, Inc. — 10 clearances - Dade Behring, Inc. — 8 clearances - Roche Diagnostic Systems, Inc. — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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