LER · Fluorescent Immunoassay, Theophylline
Clinical Toxicology · 21 CFR 862.3880 · Class 2
Overview
| Product Code | LER |
|---|---|
| Device Name | Fluorescent 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942192 | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS | Sigma Diagnostics, Inc. | Jul 13, 1994 | SESE |
| K905521 | CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION | Microgenics Corp. | Dec 26, 1990 | SESE |
| K882570 | TURBOX THEOPHYLLINE ASSAY | Unipath , Ltd. | Nov 10, 1988 | SESE |
| K864409 | IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS | Sclavo, Inc. | Dec 22, 1986 | SESE |
| K863475 | THEOFAST(TM) TEST PACKAGE | 3M Company | Nov 5, 1986 | SESE |
| K842585 | THEOPHYLLINE KIT FLUORESCENCE POLARIZA- | Windsor Laboratories, Inc. | Sep 26, 1984 | SESE |
| K840758 | IMMPULSE THEOPHYLLINE ASSAY REAGENTS | Paragon Diagnostics, Inc. | Apr 4, 1984 | SESE |
| K833070 | TDX THEOPHYLLINE | Abbott Laboratories | Nov 14, 1983 | SESE |
| K831514 | AMWA TDA THEOPHYLLINE TEST | Miles Laboratories, Inc. | Jun 30, 1983 | SESE |
| K823576 | COBAS STANDARD FOR TOTAL PROTEIN | Hoffmann-La Roche, Inc. | Jan 7, 1983 | SESE |
| K820397 | AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM | American Diagnostic Corp. | Mar 2, 1982 | SESE |
| K813240 | EMIT-AAD THEOPHYLLINE ASSAY | Syva Co. | Dec 3, 1981 | SESE |
| K812518 | AMES TDA THEOPHYLLINE TEST | Miles Laboratories, Inc. | Sep 23, 1981 | SESE |
| K811856 | FLUOROMATIC THEOPHYLLINE FIA | Bio-Rad | Jul 10, 1981 | SESE |
| K810943 | AMES TDA THEOPHYLLINE TEST | Miles Laboratories, Inc. | Apr 17, 1981 | SESE |
Top Applicants
- Miles Laboratories, Inc. — 3 clearances
- 3M Company — 1 clearance
- Abbott Laboratories — 1 clearance
- American Diagnostic Corp. — 1 clearance
- Bio-Rad — 1 clearance
