DKB · Calibrators, Drug Mixture
Clinical Toxicology · 21 CFR 862.3200 · Class 2
Overview
| Product Code | DKB |
|---|---|
| Device Name | Calibrators, Drug Mixture |
| Regulation | 21 CFR 862.3200 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
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 94)
Showing 20 most recent of 94 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141928 | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | Roche Diagnostics Operations (Rdo) | Nov 25, 2014 | SESE |
| K133710 | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | Lin-Zhi International, Inc. | Feb 21, 2014 | SESE |
| K120936 | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS | Microgenics Corporation | Dec 13, 2012 | SESE |
| K092266 | RANDOX METHAMPHETAMINE ASSAY | Randox Laboratories, Ltd. | May 9, 2011 | SESE |
| K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | Microgenics Corp. | Apr 8, 2011 | SESE |
| K090939 | ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 | Roche Diagnostics | Jun 18, 2009 | SESE |
| K090900 | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 | Siemens Healthcare Diagnostics | Jun 1, 2009 | SESE |
| K062162 | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) | Dade Behring, Inc. | Sep 14, 2006 | SESE |
| K062121 | DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) | Dade Behring, Inc. | Aug 25, 2006 | SESE |
| K060645 | PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | May 30, 2006 | SESE |
| K051088 | MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Jun 24, 2005 | SESE |
| K033879 | VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 | Maine Standards Co. | Feb 27, 2004 | SESE |
| K033306 | PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS | Roche Diagnostics Corp. | Dec 15, 2003 | SESE |
| K032574 | DIMENSION DRUG CALIBRATOR II, MODEL DC49C | Dade Behring, Inc. | Oct 6, 2003 | SESE |
| K031856 | PRECISET TDM I AND PRECISET TDM II CALIBRATORS | Roche Diagnostics Corp. | Aug 6, 2003 | SESE |
| K031775 | PRECISET DAT PLUS I CALIBRATORS | Roche Diagnostics Corp. | Aug 5, 2003 | SESE |
| K021393 | PRECISET DAT PLUS | Quantimetrix Corp. | Jun 13, 2002 | SESE |
| K013959 | BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS | Bayer Diagnostics Corp. | Jan 29, 2002 | SESE |
| K012318 | RANDOX THERAPEUTIC DRUG CALIBRATOR | Randox Laboratories, Ltd. | Sep 12, 2001 | SESE |
| K993954 | SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS | Beckman Coulter, Inc. | Jan 11, 2000 | SESE |
Top Applicants
- Syva Co. — 21 clearances
- Roche Diagnostic Systems, Inc. — 10 clearances
- Diagnostic Reagents, Inc. — 6 clearances
- Dade Behring, Inc. — 5 clearances
- Microgenics Corp. — 5 clearances
