DLJ · Calibrators, Drug Specific
Clinical Toxicology · 21 CFR 862.3200 · Class 2
Overview
| Product Code | DLJ |
|---|---|
| Device Name | Calibrators, Drug Specific |
| 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 123)
Showing 20 most recent of 123 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 | Randox Laboratories, Ltd. | Aug 8, 2013 | SESE |
| K091617 | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | Thermo Fisher Scientific | Jul 17, 2009 | SESE |
| K082030 | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 | Siemens Healthcare Diagnostics, Inc. | Aug 22, 2008 | SESE |
| K062182 | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | Dade Behring, Inc. | Sep 14, 2006 | SESE |
| K062199 | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) | Dade Behring, Inc. | Sep 6, 2006 | SESE |
| K061503 | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) | Dade Behring, Inc. | Jun 22, 2006 | SESE |
| K060503 | DIMENSION TACR CALIBRATOR, MODEL DC107 | Dade Behring, Inc. | May 18, 2006 | SESE |
| K053108 | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 | Dade Behring, Inc. | Feb 16, 2006 | SESE |
| K052015 | DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 | Dade Behring, Inc. | Sep 12, 2005 | SESE |
| K033601 | LABONE MICRO-PLATE COTININE EIA | Labone, Inc. | Feb 10, 2004 | SESE |
| K033246 | PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS | Roche Diagnostics Corp. | Dec 2, 2003 | SESE |
| K033165 | PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS | Roche Diagnostics Corp. | Oct 14, 2003 | SESE |
| K023780 | DRI PRIMIDONE CALIBRATORS | Microgenics Corp. | Feb 10, 2003 | SESE |
| K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Dec 16, 2002 | SESE |
| K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Jun 18, 2002 | SESE |
| K020845 | EMIT 2000 VANCOMYCIN CALIBRATORS | Dade Behring, Inc. | May 8, 2002 | SESE |
| K020769 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Apr 3, 2002 | SESE |
| K012109 | DRI ECSTASY URINE CALIBRATORS | Microgenics Corp. | Aug 27, 2001 | SESE |
| K011112 | CYCLOSPORINE CALIBRATOR | Dade Behring, Inc. | Jul 17, 2001 | SESE |
| K993473 | SYNCHRON SYSTEMS DRUG CALIBRATOR 2 | Beckman Coulter, Inc. | Nov 26, 1999 | SESE |
Top Applicants
- E.I. Dupont DE Nemours & Co., Inc. — 21 clearances
- Syva Co. — 18 clearances
- Innotron of Oregon, Inc. — 10 clearances
- Dade Behring, Inc. — 8 clearances
- Roche Diagnostic Systems, Inc. — 8 clearances
