FDA product code SEI: Qualitative And Quantitative Hepatitis B Virus Antibody Assays
SEI is the FDA product code for qualitative and quantitative hepatitis b virus antibody assays. It is a Class II device, regulated under 21 CFR 866.3173 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under SEI, 4 in the last five years, from 2 different applicants. The average 510(k) review took 89 days (median 90); 89 days on average over the last three years. 30 PMA applications cite this product code.
Definition
In vitro diagnostic devices intended for use in the detection of antibodies to HBV. These devices are intended to aid in the diagnosis of HBV infection in persons with signs and symptoms of hepatitis and in persons at risk for HBV infection. Anti-HBs assay results may be used as an aid in the determination of susceptibility to HBV infection in individuals prior to or following HBV vaccination or when vaccination status is unknown.
Classification
| Field | Value |
|---|---|
| Device name | Qualitative And Quantitative Hepatitis B Virus Antibody Assays |
| Device class | Class II |
| Regulation | 21 CFR 866.3173 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for SEI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 4 | 89 |
Compare with all 510(k) review times · Search every SEI clearance
Top SEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 2 | 2026-04-07 |
| Beckman Coulter, Inc. | 2 | 2026-03-13 |
Most recent SEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260049 | Roche Diagnostics | Elecsys Anti-HBc IgM | 2026-04-07 | 90 |
| K260046 | Roche Diagnostics | Elecsys Anti-HBc II | 2026-04-07 | 90 |
| K254059 | Beckman Coulter, Inc. | Access anti-HBc IgM | 2026-03-13 | 86 |
| K253687 | Beckman Coulter, Inc. | Access anti-HBc Total | 2026-02-19 | 90 |
Recalls for SEI devices
openFDA lists no recalls for product code SEI.
Frequently asked questions
What is FDA product code SEI?
SEI is the FDA product code for qualitative and quantitative hepatitis b virus antibody assays. It is a Class II device, regulated under 21 CFR 866.3173 and reviewed by the Microbiology panel.
What device class is SEI?
Class II, regulation 21 CFR 866.3173. Typical premarket route: 510(k).
How long does a 510(k) take for product code SEI?
Across 4 cleared submissions the average was 89 days from receipt to decision (median 90).
Which companies have the most SEI clearances?
Roche Diagnostics (2); Beckman Coulter, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code SEI
- Run a recall and safety report across every SEI manufacturer
- Watch product code SEI 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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