FDA product code LOL: Hepatitis A Test (Antibody And Igm Antibody)
LOL is the FDA product code for hepatitis a test (antibody and igm antibody). It is a Class II device, regulated under 21 CFR 866.3310 and reviewed by the Microbiology panel. FDA has cleared 26 510(k) submissions under LOL, 5 in the last five years, from 9 different applicants. The average 510(k) review took 136 days (median 152); 210 days on average over the last three years. 8 PMA applications cite this product code. FDA has posted 12 recalls for LOL devices.
Classification
| Field | Value |
|---|---|
| Device name | Hepatitis A Test (Antibody And Igm Antibody) |
| Device class | Class II |
| Regulation | 21 CFR 866.3310 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for LOL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 172 |
| 2020 | 1 | 73 |
| 2021 | 1 | 8 |
| 2022 | 1 | 30 |
| 2023 | 1 | 323 |
| 2025 | 1 | 267 |
| 2026 | 2 | 152 |
Compare with all 510(k) review times · Search every LOL clearance
Top LOL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| DiaSorin, Inc. | 8 | 2022-12-09 |
| Roche Diagnostics | 3 | 2026-04-07 |
| Abbott Laboratories | 3 | 2023-08-10 |
| Siemens Healthcare Diagnostics, Inc. | 3 | 2016-10-13 |
| Beckman Coulter, Inc. | 2 | 2026-01-27 |
4 more applicants have LOL clearances. See the full list in Caduvo.
Most recent LOL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260048 | Roche Diagnostics | Elecsys Anti-HAV IgM | 2026-04-07 | 90 |
| K251995 | Beckman Coulter, Inc. | Access anti-HAV IgM | 2026-01-27 | 214 |
| K243846 | Beckman Coulter, Inc. | Access anti-HAV | 2025-09-09 | 267 |
| K222850 | Abbott Laboratories | HAVAb IgG II | 2023-08-10 | 323 |
| K223403 | DiaSorin, Inc. | LIAISON Anti-HAV; LIAISON XS | 2022-12-09 | 30 |
Recalls for LOL devices
12 product recalls in 11 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-09.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code LOL?
LOL is the FDA product code for hepatitis a test (antibody and igm antibody). It is a Class II device, regulated under 21 CFR 866.3310 and reviewed by the Microbiology panel.
What device class is LOL?
Class II, regulation 21 CFR 866.3310. Typical premarket route: 510(k).
How long does a 510(k) take for product code LOL?
Across 26 cleared submissions the average was 136 days from receipt to decision (median 152).
Which companies have the most LOL clearances?
DiaSorin, Inc. (8); Roche Diagnostics (3); Abbott Laboratories (3); Siemens Healthcare Diagnostics, Inc. (3); Beckman Coulter, Inc. (2).
Have LOL devices been recalled?
Yes: 12 product recalls across 11 recall events; the most recent began 2020-03-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LOL
- Run a recall and safety report across every LOL manufacturer
- Watch product code LOL 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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