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 862.3280](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3280) → DIF — Drug Mixture Control Materials # DIF · Drug Mixture Control Materials _Clinical Toxicology · 21 CFR 862.3280 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF ## Overview - **Product Code:** DIF - **Device Name:** Drug Mixture Control Materials - **Regulation:** [21 CFR 862.3280](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3280) - **Device Class:** 1 - **Review Panel:** [Clinical Toxicology](/submissions/TX) ## Identification A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials. ## Classification Rationale Class I (general 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 202) Showing 20 most recent of 202 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K153474](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K153474.md) | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series | Biochemical Diagnostics, Inc. | Feb 23, 2016 | SESE | | [K132688](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K132688.md) | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | Biochemical Diagnostics, Inc. | Dec 16, 2013 | SESE | | [K132174](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K132174.md) | MULTICHEM WBT | Techno-Path Manufacturing , Ltd. | Sep 20, 2013 | SESE | | [K121122](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K121122.md) | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | Biochemical Diagnostic, Inc. | Jul 3, 2012 | SESE | | [K121143](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K121143.md) | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | Bio-Rad Laboratories | May 18, 2012 | SESE | | [K120504](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K120504.md) | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | Bio-Rad Laboratories, Inc. | Mar 27, 2012 | SESE | | [K103656](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K103656.md) | THERMO SCIENTIFIC MAS R DOA TOTAL | Microgenics Corporation | Mar 24, 2011 | SESE | | [K093577](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K093577.md) | LIQUICHEK OPIATE CONTROL | Bio-Rad Laboratories | Mar 12, 2010 | SESE | | [K080085](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K080085.md) | MAS TOX CONTROL | Thermo Fisher Scientific | Apr 30, 2008 | SESE | | [K080183](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K080183.md) | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 | Roche Diagnostics Corp. | Mar 25, 2008 | SESE | | [K072721](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K072721.md) | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | Bio-Rad, Diagnostics Grp. | Dec 11, 2007 | SESE | | [K063398](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K063398.md) | ESA LEADCARE II LEAD CONTROL | Bionostics, Inc. | Dec 5, 2006 | SESE | | [K062191](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K062191.md) | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 | Dade Behring, Inc. | Aug 21, 2006 | SESE | | [K060788](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K060788.md) | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Biosite Incorporated | Jul 10, 2006 | SESE | | [K060417](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K060417.md) | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | Quantimetrix Corp. | Mar 21, 2006 | SESE | | [K052053](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K052053.md) | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK | Bio-Rad | Aug 9, 2005 | SESE | | [K050682](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K050682.md) | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) | Bio-Rad Laboratories, Inc. | Apr 29, 2005 | SESE | | [K050037](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K050037.md) | TRIAGE TOX DRUG SCREEN CONTROLS | Biosite Incorporated | Mar 22, 2005 | SESE | | [K042865](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K042865.md) | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) | Bio-Rad | Nov 24, 2004 | SESE | | [K041666](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K041666.md) | DC-ACETA/SAL CONTROLS | Diagnostic Chemicals , Ltd. | Aug 17, 2004 | SESE | ## Top Applicants - Bio-Rad — 31 clearances - Roche Diagnostic Systems, Inc. — 14 clearances - Medical Analysis Systems, Inc. — 13 clearances - Syva Co. — 13 clearances - Utak Laboratories, Inc. — 13 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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