DIF · Drug Mixture Control Materials
Clinical Toxicology · 21 CFR 862.3280 · Class 1
Overview
| Product Code | DIF |
|---|---|
| Device Name | Drug Mixture 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 202)
Showing 20 most recent of 202 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153474 | 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 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | Biochemical Diagnostics, Inc. | Dec 16, 2013 | SESE |
| K132174 | MULTICHEM WBT | Techno-Path Manufacturing , Ltd. | Sep 20, 2013 | SESE |
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | Biochemical Diagnostic, Inc. | Jul 3, 2012 | SESE |
| K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | Bio-Rad Laboratories | May 18, 2012 | SESE |
| K120504 | 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 | THERMO SCIENTIFIC MAS R DOA TOTAL | Microgenics Corporation | Mar 24, 2011 | SESE |
| K093577 | LIQUICHEK OPIATE CONTROL | Bio-Rad Laboratories | Mar 12, 2010 | SESE |
| K080085 | MAS TOX CONTROL | Thermo Fisher Scientific | Apr 30, 2008 | SESE |
| K080183 | 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 | LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC | Bio-Rad, Diagnostics Grp. | Dec 11, 2007 | SESE |
| K063398 | ESA LEADCARE II LEAD CONTROL | Bionostics, Inc. | Dec 5, 2006 | SESE |
| K062191 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 | Dade Behring, Inc. | Aug 21, 2006 | SESE |
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 | Biosite Incorporated | Jul 10, 2006 | SESE |
| K060417 | MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL | Quantimetrix Corp. | Mar 21, 2006 | SESE |
| K052053 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK | Bio-Rad | Aug 9, 2005 | SESE |
| K050682 | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) | Bio-Rad Laboratories, Inc. | Apr 29, 2005 | SESE |
| K050037 | TRIAGE TOX DRUG SCREEN CONTROLS | Biosite Incorporated | Mar 22, 2005 | SESE |
| K042865 | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) | Bio-Rad | Nov 24, 2004 | SESE |
| K041666 | 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
