FDA product code LCA: Radioimmunoassay, Theophylline
LCA is the FDA product code for radioimmunoassay, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under LCA, from 5 different applicants. The average 510(k) review took 62 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Theophylline |
| Device class | Class II |
| Regulation | 21 CFR 862.3880 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LCA clearance
Top LCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Photec Diagnostics, Inc. | 1 | 1988-03-24 |
| Medical & Scientific Designs, Inc. | 1 | 1984-01-24 |
| Kallestad Laboratories, Inc. | 1 | 1982-07-06 |
| Bioclinical Corp. | 1 | 1982-05-28 |
| Ria Diagnostics | 1 | 1980-02-25 |
Most recent LCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880291 | Photec Diagnostics, Inc. | THEOPHYLLINE TEST KIT REF. #A874799 | 1988-03-24 | 59 |
| K833789 | Medical & Scientific Designs, Inc. | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | 1984-01-24 | 85 |
| K821862 | Kallestad Laboratories, Inc. | QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. | 1982-07-06 | 12 |
| K821347 | Bioclinical Corp. | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. | 1982-05-28 | 23 |
| K792062 | Ria Diagnostics | THEOPHYLLINE RIASSAY | 1980-02-25 | 133 |
Recalls for LCA devices
openFDA lists no recalls for product code LCA.
Frequently asked questions
What is FDA product code LCA?
LCA is the FDA product code for radioimmunoassay, theophylline. It is a Class II device, regulated under 21 CFR 862.3880 and reviewed by the Clinical Toxicology panel.
What device class is LCA?
Class II, regulation 21 CFR 862.3880. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCA?
Across 5 cleared submissions the average was 62 days from receipt to decision (median 59).
Which companies have the most LCA clearances?
Photec Diagnostics, Inc. (1); Medical & Scientific Designs, Inc. (1); Kallestad Laboratories, Inc. (1); Bioclinical Corp. (1); Ria Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCA
- Run a recall and safety report across every LCA manufacturer
- Watch product code LCA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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