FDA product code LFM: Enzyme Immunoassay, Digitoxin
LFM is the FDA product code for enzyme immunoassay, digitoxin. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel. FDA has cleared 20 510(k) submissions under LFM, from 14 different applicants. The average 510(k) review took 73 days (median 63). FDA has posted 5 recalls for LFM devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Digitoxin |
| Device class | Class II |
| Regulation | 21 CFR 862.3300 |
| 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 LFM clearance
Top LFM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Products Corp. | 4 | 1994-10-27 |
| Abbott Laboratories | 3 | 1996-09-10 |
| Dade Behring, Inc. | 2 | 2006-07-28 |
| Randox Laboratories, Ltd. | 1 | 2002-01-11 |
| Chiron Diagnostics Corp. | 1 | 1997-07-14 |
9 more applicants have LFM clearances. See the full list in Caduvo.
Most recent LFM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062024 | Dade Behring, Inc. | DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE | 2006-07-28 | 10 |
| K012112 | Randox Laboratories, Ltd. | RANDOX DIGITOXIN | 2002-01-11 | 189 |
| K990251 | Dade Behring, Inc. | DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 | 1999-03-31 | 63 |
| K970546 | Chiron Diagnostics Corp. | ACS DIGITOXIN | 1997-07-14 | 152 |
| K963158 | Abbott Laboratories | ABBOTT AXSYM DIGITOXIN (MODIFY) | 1996-09-10 | 46 |
Recalls for LFM devices
5 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-12-05.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code LFM?
LFM is the FDA product code for enzyme immunoassay, digitoxin. It is a Class II device, regulated under 21 CFR 862.3300 and reviewed by the Clinical Toxicology panel.
What device class is LFM?
Class II, regulation 21 CFR 862.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFM?
Across 20 cleared submissions the average was 73 days from receipt to decision (median 63).
Which companies have the most LFM clearances?
Diagnostic Products Corp. (4); Abbott Laboratories (3); Dade Behring, Inc. (2); Randox Laboratories, Ltd. (1); Chiron Diagnostics Corp. (1).
Have LFM devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2024-12-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LFM
- Run a recall and safety report across every LFM manufacturer
- Watch product code LFM 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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