LCA · Radioimmunoassay, Theophylline
Clinical Toxicology · 21 CFR 862.3880 · Class 2
Overview
| Product Code | LCA |
|---|---|
| Device Name | Radioimmunoassay, 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Photec Diagnostics, Inc. | Mar 24, 1988 | SESE |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | Medical & Scientific Designs, Inc. | Jan 24, 1984 | SESE |
| K821862 | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. | Kallestad Laboratories, Inc. | Jul 6, 1982 | SESE |
| K821347 | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. | Bioclinical Corp. | May 28, 1982 | SESE |
| K792062 | THEOPHYLLINE RIASSAY | Ria Diagnostics | Feb 25, 1980 | SESE |
Top Applicants
- Bioclinical Corp. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- Medical & Scientific Designs, Inc. — 1 clearance
- Photec Diagnostics, Inc. — 1 clearance
- Ria Diagnostics — 1 clearance
