FDA product code LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs
LFG is the FDA product code for radioimmunoassay, 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 21 510(k) submissions under LFG, from 10 different applicants. The average 510(k) review took 72 days (median 52). FDA has posted 2 recalls for LFG devices, 1 initiated in the last five years.
Definition
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, 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 LFG clearance
Top LFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 9 | 1987-03-20 |
| Guangzhou Wondfo Biotech Co., Ltd. | 2 | 2014-12-18 |
| Ucp Biosciences, Inc. | 2 | 2007-09-20 |
| Wien Laboratories, Inc. | 2 | 1982-06-14 |
| Healgen Scientific,, LLC | 1 | 2015-08-18 |
5 more applicants have LFG clearances. See the full list in Caduvo.
Most recent LFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151348 | Healgen Scientific,, LLC | Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) | 2015-08-18 | 90 |
| K142609 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | 2014-12-18 | 93 |
| K112395 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST | 2011-09-09 | 21 |
| K072062 | Ucp Biosciences, Inc. | UCP MULTIPLE DRUG SCREEN TEST CUPS | 2007-09-20 | 55 |
| K061457 | Ucp Biosciences, Inc. | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS | 2006-08-21 | 88 |
Recalls for LFG devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2026-06-26.
| Year | Recalls |
|---|---|
| 2026 | 1 |
Frequently asked questions
What is FDA product code LFG?
LFG is the FDA product code for radioimmunoassay, 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 LFG?
Class II, regulation 21 CFR 862.3910. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFG?
Across 21 cleared submissions the average was 72 days from receipt to decision (median 52).
Which companies have the most LFG clearances?
Syva Co. (9); Guangzhou Wondfo Biotech Co., Ltd. (2); Ucp Biosciences, Inc. (2); Wien Laboratories, Inc. (2); Healgen Scientific,, LLC (1).
Have LFG devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-06-26.
Next steps
- Run an FDA pathway report with predicate devices for product code LFG
- Run a recall and safety report across every LFG manufacturer
- Watch product code LFG 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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