FDA product code LCD: Enzyme Immunoassay, Gentamicin
LCD is the FDA product code for enzyme immunoassay, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 37 510(k) submissions under LCD, 1 in the last five years, from 23 different applicants. The average 510(k) review took 69 days (median 39); 239 days on average over the last three years. FDA has posted 13 recalls for LCD devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Gentamicin |
| Device class | Class II |
| Regulation | 21 CFR 862.3450 |
| 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 LCD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 239 |
Compare with all 510(k) review times · Search every LCD clearance
Top LCD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 8 | 1987-12-18 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 1990-10-15 |
| Abbott Laboratories | 2 | 2025-07-09 |
| Seradyn, Inc. | 2 | 2006-06-15 |
| Diagnostic Products Corp. | 2 | 2001-08-20 |
18 more applicants have LCD clearances. See the full list in Caduvo.
Most recent LCD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243500 | Abbott Laboratories | ARCHITECT iGentamicin | 2025-07-09 | 239 |
| K102699 | Abbott Laboratories | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS | 2011-04-01 | 193 |
| K060709 | Seradyn, Inc. | MULTIGENT GENTAMICIN | 2006-06-15 | 91 |
| K042479 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE | 2005-01-06 | 115 |
| K020704 | Roche Diagnostics Corp. | ROCHE ONLINE GENTAMICIN | 2002-07-12 | 130 |
Recalls for LCD devices
13 product recalls in 9 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-04-24.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code LCD?
LCD is the FDA product code for enzyme immunoassay, gentamicin. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is LCD?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCD?
Across 37 cleared submissions the average was 69 days from receipt to decision (median 39).
Which companies have the most LCD clearances?
Syva Co. (8); E.I. Dupont DE Nemours & Co., Inc. (3); Abbott Laboratories (2); Seradyn, Inc. (2); Diagnostic Products Corp. (2).
Have LCD devices been recalled?
Yes: 13 product recalls across 9 recall events; the most recent began 2020-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LCD
- Run a recall and safety report across every LCD manufacturer
- Watch product code LCD 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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