FDA product code LGI: Fluorescence Polarization Immunoassay, Carbamazepine
LGI is the FDA product code for fluorescence polarization immunoassay, carbamazepine. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel. FDA has cleared 3 510(k) submissions under LGI, from 3 different applicants. The average 510(k) review took 91 days (median 83). FDA has posted 4 recalls for LGI devices.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Polarization Immunoassay, Carbamazepine |
| Device class | Class II |
| Regulation | 21 CFR 862.3645 |
| 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 LGI clearance
Top LGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 1 | 1994-11-10 |
| Abbott Laboratories | 1 | 1994-06-21 |
| Innotron of Oregon, Inc. | 1 | 1990-04-12 |
Most recent LGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944063 | Sigma Diagnostics, Inc. | FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE | 1994-11-10 | 83 |
| K940682 | Abbott Laboratories | AXSYM(TM) QUINIDINE | 1994-06-21 | 131 |
| K900702 | Innotron of Oregon, Inc. | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | 1990-04-12 | 59 |
Recalls for LGI devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-05-31.
Frequently asked questions
What is FDA product code LGI?
LGI is the FDA product code for fluorescence polarization immunoassay, carbamazepine. It is a Class II device, regulated under 21 CFR 862.3645 and reviewed by the Clinical Toxicology panel.
What device class is LGI?
Class II, regulation 21 CFR 862.3645. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGI?
Across 3 cleared submissions the average was 91 days from receipt to decision (median 83).
Which companies have the most LGI clearances?
Sigma Diagnostics, Inc. (1); Abbott Laboratories (1); Innotron of Oregon, Inc. (1).
Have LGI devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2007-05-31.
Next steps
- Run an FDA pathway report with predicate devices for product code LGI
- Run a recall and safety report across every LGI manufacturer
- Watch product code LGI 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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