LAS · Drug Specific Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | LAS |
|---|---|
| Device Name | Drug Specific Control Materials |
| Regulation | 21 CFR 862.3280 |
| Device Class | Class 1 |
| Review Panel | Clinical Toxicology |
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 | CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS | Chromsystems Instruments & Chemicals GmbH | Nov 17, 2009 | SESE |
| K072257 | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL | More Diagnostics | Jan 30, 2008 | SESE |
| K062942 | QUANTIMETRIX NICOSURE COTININE URINE CONTROL | Quantimetrix Corp. | Oct 30, 2006 | SESE |
| K051074 | MAS IMMUNOSUPPRESSANT CONTROLS | Microgenics Corp. | Jun 6, 2005 | SESE |
| K040411 | DRI OXYCODONE ASSAY | Microgenics Corp. | May 27, 2004 | SESE |
| K032842 | MICROGENICS CYCLOSPORINE CONTROL KIT | Microgenics Corp. | Oct 17, 2003 | SESE |
| K030616 | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 | Microgenics Corp. | Mar 31, 2003 | SESE |
| K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | Consolidated Technologies, Inc. | Jul 14, 1999 | SESE |
| K970517 | INNOFLUOR TOPIRAMATE CONTROL SET | Oxis Intl., Inc. | May 12, 1997 | SESE |
| K971210 | SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS | Beckman Instruments, Inc. | Apr 17, 1997 | SESE |
| K946119 | ROCHE-TDM ONLEIN(TM) CONTROLS | Roche Diagnostic Systems, Inc. | Feb 7, 1995 | SESE |
| K943048 | MICROGENICS THC CONTROL SETS | Microgenics Corp. | Aug 24, 1994 | SESE |
| K930844 | ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE | Roche Diagnostic Systems, Inc. | Jan 27, 1994 | SESE |
| K934145 | DUPONT ACA URINE METHADONE CONTROL | E.I. Dupont DE Nemours & Co., Inc. | Nov 9, 1993 | SESE |
| K933557 | REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE | Consolidated Technologies, Inc. | Sep 10, 1993 | SESE |
| K932662 | CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL | More Diagnostics | Jul 26, 1993 | SESE |
| K921939 | SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) | Heraeus Kulzer, Inc. | Jul 16, 1992 | SESE |
| K921141 | CANNABINOID URINE CONTROLS | Diagnostic Reagents, Inc. | Apr 17, 1992 | SESE |
| K915516 | ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL | Roche Diagnostic Systems, Inc. | Jan 28, 1992 | SESE |
| K913677 | 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
