FDA product code LCS: Radioimmunoassay, Digoxin (125-I)
LCS is the FDA product code for radioimmunoassay, digoxin (125-i). It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 15 510(k) submissions under LCS, from 15 different applicants. The average 510(k) review took 39 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I) |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| 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 LCS clearance
Top LCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Monobind | 1 | 1992-08-24 |
| Seradyn, Inc. | 1 | 1991-08-30 |
| Innotron of Oregon, Inc. | 1 | 1989-10-30 |
| Cyberfluor, Inc. | 1 | 1989-01-17 |
| Sclavo, Inc. | 1 | 1988-02-19 |
10 more applicants have LCS clearances. See the full list in Caduvo.
Most recent LCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922353 | Monobind | DIGOXIN COATED TUBE RIA | 1992-08-24 | 97 |
| K913562 | Seradyn, Inc. | QMS - DIGOXIN | 1991-08-30 | 21 |
| K895828 | Innotron of Oregon, Inc. | INNOFLUOR DIGOXIN REAGENT SET | 1989-10-30 | 28 |
| K884707 | Cyberfluor, Inc. | FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT | 1989-01-17 | 69 |
| K874748 | Sclavo, Inc. | IMMPULSE DIGOXIN ASSAY REAGENTS | 1988-02-19 | 93 |
Recalls for LCS devices
openFDA lists no recalls for product code LCS.
Frequently asked questions
What is FDA product code LCS?
LCS is the FDA product code for radioimmunoassay, digoxin (125-i). It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is LCS?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCS?
Across 15 cleared submissions the average was 39 days from receipt to decision (median 22).
Which companies have the most LCS clearances?
Monobind (1); Seradyn, Inc. (1); Innotron of Oregon, Inc. (1); Cyberfluor, Inc. (1); Sclavo, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LCS
- Run a recall and safety report across every LCS manufacturer
- Watch product code LCS 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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