FDA product code LFH: U.V. Spectrometry, Tricyclic Antidepressant Drugs
LFH is the FDA product code for u.v. spectrometry, 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 6 510(k) submissions under LFH, 2 in the last five years, from 4 different applicants. The average 510(k) review took 153 days (median 100). FDA has posted 3 recalls for LFH devices.
Classification
| Field | Value |
|---|---|
| Device name | U.V. Spectrometry, 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 |
510(k) clearances per year for LFH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 373 |
| 2023 | 1 | 221 |
Top LFH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Microgenics Corporation | 2 | 2023-11-17 |
| Diagnostic Reagents, Inc. | 2 | 1998-11-18 |
| Princeton BioMeditech Corp. | 1 | 1998-08-25 |
| Abbott Laboratories | 1 | 1995-11-22 |
Most recent LFH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231020 | Microgenics Corporation | Alinity c Tricyclic Antidepressants Reagent Kit | 2023-11-17 | 221 |
| K213875 | Microgenics Corporation | DRI TM Tricyclics Serum Tox Assay | 2022-12-21 | 373 |
| K983268 | Diagnostic Reagents, Inc. | MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY | 1998-11-18 | 62 |
| K981801 | Princeton BioMeditech Corp. | ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA | 1998-08-25 | 96 |
| K961393 | Diagnostic Reagents, Inc. | TRICYCLICS SERUM TOX ASSAY | 1996-06-12 | 62 |
Recalls for LFH devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-12-15.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code LFH?
LFH is the FDA product code for u.v. spectrometry, 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 LFH?
Class II, regulation 21 CFR 862.3910. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFH?
Across 6 cleared submissions the average was 153 days from receipt to decision (median 100).
Which companies have the most LFH clearances?
Microgenics Corporation (2); Diagnostic Reagents, Inc. (2); Princeton BioMeditech Corp. (1); Abbott Laboratories (1).
Have LFH devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2017-12-15.
Next steps
- Run an FDA pathway report with predicate devices for product code LFH
- Run a recall and safety report across every LFH manufacturer
- Watch product code LFH 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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