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) → LAS — Drug Specific Control Materials # LAS · Drug Specific 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/LAS ## Overview - **Product Code:** LAS - **Device Name:** Drug Specific 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 83) Showing 20 most recent of 83 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K080459](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K080459.md) | CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS | Chromsystems Instruments & Chemicals GmbH | Nov 17, 2009 | SESE | | [K072257](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K072257.md) | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | More Diagnostics | Jan 30, 2008 | SESE | | [K062942](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K062942.md) | QUANTIMETRIX NICOSURE COTININE URINE CONTROL | Quantimetrix Corp. | Oct 30, 2006 | SESE | | [K051074](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K051074.md) | MAS IMMUNOSUPPRESSANT CONTROLS | Microgenics Corp. | Jun 6, 2005 | SESE | | [K040411](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K040411.md) | DRI OXYCODONE ASSAY | Microgenics Corp. | May 27, 2004 | SESE | | [K032842](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K032842.md) | MICROGENICS CYCLOSPORINE CONTROL KIT | Microgenics Corp. | Oct 17, 2003 | SESE | | [K030616](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K030616.md) | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 | Microgenics Corp. | Mar 31, 2003 | SESE | | [K992151](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K992151.md) | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | Consolidated Technologies, Inc. | Jul 14, 1999 | SESE | | [K970517](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K970517.md) | INNOFLUOR TOPIRAMATE CONTROL SET | Oxis Intl., Inc. | May 12, 1997 | SESE | | [K971210](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K971210.md) | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS | Beckman Instruments, Inc. | Apr 17, 1997 | SESE | | [K946119](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K946119.md) | ROCHE-TDM ONLEIN(TM) CONTROLS | Roche Diagnostic Systems, Inc. | Feb 7, 1995 | SESE | | [K943048](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K943048.md) | MICROGENICS THC CONTROL SETS | Microgenics Corp. | Aug 24, 1994 | SESE | | [K930844](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K930844.md) | ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE | Roche Diagnostic Systems, Inc. | Jan 27, 1994 | SESE | | [K934145](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K934145.md) | DUPONT ACA URINE METHADONE CONTROL | E.I. Dupont DE Nemours & Co., Inc. | Nov 9, 1993 | SESE | | [K933557](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K933557.md) | REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE | Consolidated Technologies, Inc. | Sep 10, 1993 | SESE | | [K932662](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K932662.md) | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL | More Diagnostics | Jul 26, 1993 | SESE | | [K921939](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K921939.md) | SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) | Heraeus Kulzer, Inc. | Jul 16, 1992 | SESE | | [K921141](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K921141.md) | CANNABINOID URINE CONTROLS | Diagnostic Reagents, Inc. | Apr 17, 1992 | SESE | | [K915516](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K915516.md) | ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL | Roche Diagnostic Systems, Inc. | Jan 28, 1992 | SESE | | [K913677](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS/K913677.md) | ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III | Analytical Control Systems, Inc. | Sep 25, 1991 | SESE | ## Top Applicants - Syva Co. — 22 clearances - Roche Diagnostic Systems, Inc. — 14 clearances - Utak Laboratories, Inc. — 8 clearances - Hemometrix — 6 clearances - Microgenics Corp. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAS) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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