FDA product code LOM: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
LOM is the FDA product code for test, hepatitis b (b antigen, b surface antigen, be antigen). It is a Class II device, regulated under 21 CFR 866.3172 and reviewed by the Microbiology panel. Devices under LOM reach the market by 510(k); FDA lists no cleared 510(k)s for it. 62 PMA applications cite this product code. FDA has posted 33 recalls for LOM devices, 5 initiated in the last five years.
Definition
In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.
Classification
| Field | Value |
|---|---|
| Device name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Device class | Class II |
| Regulation | 21 CFR 866.3172 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for LOM devices
33 product recalls in 23 recall events; 5 initiated in the last five years and 7 still open. Most recent: 2025-04-24.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LOM?
LOM is the FDA product code for test, hepatitis b (b antigen, b surface antigen, be antigen). It is a Class II device, regulated under 21 CFR 866.3172 and reviewed by the Microbiology panel.
What device class is LOM?
Class II, regulation 21 CFR 866.3172. Typical premarket route: 510(k).
Have LOM devices been recalled?
Yes: 33 product recalls across 23 recall events; the most recent began 2025-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LOM
- Run a recall and safety report across every LOM manufacturer
- Watch product code LOM 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.