Product Code: LCA
FDA class 2
21 CFR 862.3880
Radioimmunoassay, Theophylline
Clinical Toxicology
Radioimmunoassay for theophylline is a test system using radiolabeled tracers to measure serum theophylline levels in patients receiving the bronchodilator for asthma or COPD, where therapeutic drug monitoring is essential due to its narrow therapeutic index. FDA Class 2 classification applies, requiring 510(k) premarket clearance. The product code is LCA, regulated under 21 CFR 862.3880, in the Clinical Toxicology specialty. Third-party review is available.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
8
Basic Information
- Product Code
- LCA
- Device Class
- FDA class 2
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Mar 24, 1988 | Substantially Equivalent | Photec Diagnostics, Inc. |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | Jan 24, 1984 | Substantially Equivalent | Medical & Scientific Designs, Inc. |
| K821862 | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. | Jul 06, 1982 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K821347 | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. | May 28, 1982 | Substantially Equivalent | Bioclinical Corp. |
| K792062 | THEOPHYLLINE RIASSAY | Feb 25, 1980 | Substantially Equivalent | Ria Diagnostics |