FDA product code LGD: Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
LGD is the FDA product code for enzyme linked immunoabsorbent assay, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel. FDA has cleared 106 510(k) submissions under LGD, 4 in the last five years, from 51 different applicants. The average 510(k) review took 155 days (median 122); 216 days on average over the last three years. FDA has posted 7 recalls for LGD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Device class | Class II |
| Regulation | 21 CFR 866.3780 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LGD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 270 |
| 2022 | 1 | 444 |
| 2024 | 2 | 173 |
| 2025 | 1 | 260 |
Compare with all 510(k) review times · Search every LGD clearance
Top LGD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 12 | 2024-08-30 |
| Beckman Coulter, Inc. | 7 | 2025-03-28 |
| Gull Laboratories, Inc. | 6 | 1997-03-24 |
| Labsystems, Inc. | 5 | 1989-02-07 |
| Diamedix Corp. | 4 | 2000-07-07 |
46 more applicants have LGD clearances. See the full list in Caduvo.
Most recent LGD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242022 | Beckman Coulter, Inc. | Access Toxo IgG | 2025-03-28 | 260 |
| K242095 | Beckman Coulter, Inc. | Access Toxo IgM II | 2024-10-11 | 86 |
| K233932 | Abbott Laboratories | Alinity i Toxo IgM | 2024-08-30 | 260 |
| K210596 | Abbott Laboratories | ARCHITECT Toxo IgG | 2022-05-19 | 444 |
| K162678 | Roche Diagnostics | Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl | 2017-06-23 | 270 |
Recalls for LGD devices
7 product recalls in 6 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2025-05-30.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LGD?
LGD is the FDA product code for enzyme linked immunoabsorbent assay, toxoplasma gondii. It is a Class II device, regulated under 21 CFR 866.3780 and reviewed by the Microbiology panel.
What device class is LGD?
Class II, regulation 21 CFR 866.3780. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGD?
Across 106 cleared submissions the average was 155 days from receipt to decision (median 122).
Which companies have the most LGD clearances?
Abbott Laboratories (12); Beckman Coulter, Inc. (7); Gull Laboratories, Inc. (6); Labsystems, Inc. (5); Diamedix Corp. (4).
Have LGD devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-05-30.
Next steps
- Run an FDA pathway report with predicate devices for product code LGD
- Run a recall and safety report across every LGD manufacturer
- Watch product code LGD 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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