KLS · Enzyme Immunoassay, Theophylline
Clinical Toxicology · 21 CFR 862.3880 · Class 2
Overview
| Product Code | KLS |
|---|---|
| Device Name | Enzyme Immunoassay, Theophylline |
| Regulation | 21 CFR 862.3880 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042520 | VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | Nov 30, 2004 | SESE |
| K042407 | EMIT CAFFEINE ASSAY | Dade Behring, Inc. | Oct 28, 2004 | SESE |
| K020740 | ROCHE ONLINE THEOPHYLLINE | Roche Diagnostics Corp. | Apr 16, 2002 | SESE |
| K011771 | RANDOX THEOPHYLLINE | Randox Laboratories, Ltd. | Jan 17, 2002 | SESE |
| K013272 | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY | Bayer Corp. | Oct 25, 2001 | SESE |
| K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 | Syva Co., Dade Behring, Inc. | May 10, 2001 | SESE |
| K993029 | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 | Syva Co. | Jan 27, 2000 | SESE |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | Schiapparelli Biosystems, Inc. | Nov 12, 1997 | SESE |
| K972495 | ACCUMETER THEOPHYLLINE TEST | Chemtrak, Inc. | Oct 10, 1997 | SESE |
| K961462 | CEDIA THEOPHYLLINE ASSAY | Boehringer Mannheim Corp. | Jun 27, 1996 | SESE |
| K954569 | IMMULITE THEOPHYLLINE | Diagnostic Products Corp. | Nov 13, 1995 | SESE |
| K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | Aug 11, 1995 | SESE |
| K943979 | IL TEST THEOPHYLLINE | Instrumentation Laboratory CO | Jan 18, 1995 | SESE |
| K935373 | AXSYM THEOPHYLLINE | Abbott Laboratories | Jun 21, 1994 | SESE |
| K932685 | PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS | Baxter Diagnostics, Inc. | Sep 24, 1993 | SESE |
| K933258 | VIDAS THEOPHYLLINE(THEO) | Biomerieux Vitek, Inc. | Aug 16, 1993 | SESE |
| K926245 | ABBOTT VISION THEOPHYLLINE IIA | Abbott Laboratories | May 6, 1993 | SESE |
| K913123 | EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS | Syva Co. | Sep 19, 1991 | SESE |
| K911060 | IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM | Immunomatrix | May 8, 1991 | SESE |
| K910697 | IL THEOPHYLLINE ASSAY SYSTEM | Instrumentation Laboratory CO | Apr 3, 1991 | SESE |
Top Applicants
- Syva Co. — 11 clearances
- Abbott Laboratories — 7 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 3 clearances
- Beckman Instruments, Inc. — 2 clearances
- Diagnostic Products Corp. — 2 clearances
