LGS · Fluorescence Polarization Immunoassay, Theophylline
Clinical Toxicology · 21 CFR 862.3880 · Class 2
Overview
| Product Code | LGS |
|---|---|
| Device Name | Fluorescence Polarization 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070810 | ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) | Biokit, S.A. | Jun 8, 2007 | SESE |
| K955567 | INNOFLUOR THEOPHYLLINE ASSAY SYSTEM | Oxis Intl., Inc. | Jan 24, 1996 | SESE |
| K953016 | AXSYM THEOPHYLLINE II | Abbott Laboratories | Aug 24, 1995 | SESE |
| K951169 | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Jun 20, 1995 | SESE |
| K942991 | QMS THEOPHYLLINE CS | Seradyn, Inc. | Sep 9, 1994 | SESE |
| K932127 | TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II | Abbott Laboratories | Aug 9, 1993 | SESE |
| K922991 | ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE | Abbott Laboratories | Aug 27, 1992 | SESE |
| K900706 | MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA | Innotron of Oregon, Inc. | Apr 12, 1990 | SESE |
| K894529 | FPR THEOPHYLLINE KIT | Colony Laboratories, Inc. | Sep 15, 1989 | SESE |
| K871484 | COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS | Roche Diagnostic Systems, Inc. | May 28, 1987 | SESE |
| K870277 | MONITORX LASERX THEOPHYLLINE REAGENT SET | American Monitor Corp. | Feb 18, 1987 | SESE |
| K850629 | INNOFLUOR THEOPHYLLINE | Innotron Diagnostics | Mar 12, 1985 | SESE |
| K843826 | COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL | Roche Diagnostic Systems, Inc. | Feb 1, 1985 | SESE |
Top Applicants
- Abbott Laboratories — 3 clearances
- Roche Diagnostic Systems, Inc. — 2 clearances
- American Monitor Corp. — 1 clearance
- Biokit, S.A. — 1 clearance
- Ciba Corning Diagnostics Corp. — 1 clearance
