FDA product code LFT: Fluorescent Immunoassay, Primidone
LFT is the FDA product code for fluorescent immunoassay, primidone. It is a Class II device, regulated under 21 CFR 862.3680 and reviewed by the Clinical Toxicology panel. FDA has cleared 8 510(k) submissions under LFT, from 8 different applicants. The average 510(k) review took 35 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescent Immunoassay, Primidone |
| Device class | Class II |
| Regulation | 21 CFR 862.3680 |
| 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 LFT clearance
Top LFT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 1995-03-21 |
| Baxter Healthcare Corp | 1 | 1990-11-28 |
| Tudor Laboratories, Inc. | 1 | 1989-10-20 |
| Roche Diagnostic Systems, Inc. | 1 | 1985-06-25 |
| American Dade | 1 | 1984-07-11 |
3 more applicants have LFT clearances. See the full list in Caduvo.
Most recent LFT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950028 | Sigma Diagnostics, Inc. | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS | 1995-03-21 | 76 |
| K904683 | Baxter Healthcare Corp | STRATUS PRIMIDONE FLUOROMETRIC ENZYME | 1990-11-28 | 44 |
| K895567 | Tudor Laboratories, Inc. | PRIMIDONE (FPIA) KIT | 1989-10-20 | 44 |
| K852318 | Roche Diagnostic Systems, Inc. | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS | 1985-06-25 | 25 |
| K842196 | American Dade | STRATUS PRIMIDONE FLOROMETRIC ENZY | 1984-07-11 | 37 |
Recalls for LFT devices
openFDA lists no recalls for product code LFT.
Frequently asked questions
What is FDA product code LFT?
LFT is the FDA product code for fluorescent immunoassay, primidone. It is a Class II device, regulated under 21 CFR 862.3680 and reviewed by the Clinical Toxicology panel.
What device class is LFT?
Class II, regulation 21 CFR 862.3680. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFT?
Across 8 cleared submissions the average was 35 days from receipt to decision (median 31).
Which companies have the most LFT clearances?
Sigma Diagnostics, Inc. (1); Baxter Healthcare Corp (1); Tudor Laboratories, Inc. (1); Roche Diagnostic Systems, Inc. (1); American Dade (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LFT
- Run a recall and safety report across every LFT manufacturer
- Watch product code LFT 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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