FDA product code LFI: High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs
LFI is the FDA product code for high pressure liquid chromatography, tricyclic antidepressant drugs. It is a Class II device, regulated under 21 CFR 862.3910 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under LFI, from 3 different applicants. The average 510(k) review took 283 days (median 329).
Classification
| Field | Value |
|---|---|
| Device name | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs |
| Device class | Class II |
| Regulation | 21 CFR 862.3910 |
| 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 LFI clearance
Top LFI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 2 | 1995-03-20 |
| Biosite Incorporated | 1 | 1994-12-02 |
| Technicon Instruments Corp. | 1 | 1980-10-10 |
Most recent LFI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941994 | Bio-Rad | BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC | 1995-03-20 | 329 |
| K941990 | Bio-Rad | BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC | 1995-03-20 | 329 |
| K934340 | Biosite Incorporated | BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS | 1994-12-02 | 450 |
| K802245 | Technicon Instruments Corp. | 7 TRICYCLIC ANTIDE PRESSANTS | 1980-10-10 | 24 |
Recalls for LFI devices
openFDA lists no recalls for product code LFI.
Frequently asked questions
What is FDA product code LFI?
LFI is the FDA product code for high pressure liquid chromatography, tricyclic antidepressant drugs. It is a Class II device, regulated under 21 CFR 862.3910 and reviewed by the Clinical Toxicology panel.
What device class is LFI?
Class II, regulation 21 CFR 862.3910. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFI?
Across 4 cleared submissions the average was 283 days from receipt to decision (median 329).
Which companies have the most LFI clearances?
Bio-Rad (2); Biosite Incorporated (1); Technicon Instruments Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LFI
- Run a recall and safety report across every LFI manufacturer
- Watch product code LFI 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times