FDA product code LFX: Enzyme Linked Immunoabsorbent Assay, Rubella
LFX is the FDA product code for enzyme linked immunoabsorbent assay, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel. FDA has cleared 94 510(k) submissions under LFX, 2 in the last five years, from 50 different applicants. The average 510(k) review took 172 days (median 136); 263 days on average over the last three years. FDA has posted 15 recalls for LFX devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Device class | Class II |
| Regulation | 21 CFR 866.3510 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LFX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 263 |
Compare with all 510(k) review times · Search every LFX clearance
Top LFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 8 | 2025-06-20 |
| Diamedix Corp. | 5 | 2011-01-21 |
| Zeus Scientific, Inc. | 5 | 2007-03-21 |
| Gull Laboratories, Inc. | 5 | 1995-08-04 |
| Ortho Diagnostic Systems, Inc. | 5 | 1990-12-04 |
45 more applicants have LFX clearances. See the full list in Caduvo.
Most recent LFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250588 | Beckman Coulter, Inc. | Access Rubella IgG | 2025-11-17 | 263 |
| K243168 | Abbott Laboratories | Alinity i Rubella IgG | 2025-06-20 | 263 |
| K122397 | DiaSorin, Inc. | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM | 2012-09-06 | 30 |
| K093101 | Diamedix Corp. | MAGO 4S | 2011-01-21 | 477 |
| K092587 | Bio-Rad Laboratories | BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM | 2010-12-03 | 466 |
Recalls for LFX devices
15 product recalls in 12 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-09-22.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code LFX?
LFX is the FDA product code for enzyme linked immunoabsorbent assay, rubella. It is a Class II device, regulated under 21 CFR 866.3510 and reviewed by the Microbiology panel.
What device class is LFX?
Class II, regulation 21 CFR 866.3510. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFX?
Across 94 cleared submissions the average was 172 days from receipt to decision (median 136).
Which companies have the most LFX clearances?
Abbott Laboratories (8); Diamedix Corp. (5); Zeus Scientific, Inc. (5); Gull Laboratories, Inc. (5); Ortho Diagnostic Systems, Inc. (5).
Have LFX devices been recalled?
Yes: 15 product recalls across 12 recall events; the most recent began 2021-09-22.
Next steps
- Run an FDA pathway report with predicate devices for product code LFX
- Run a recall and safety report across every LFX manufacturer
- Watch product code LFX 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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