FDA product code SGG: Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
SGG is the FDA product code for mass spectrometric, immunoglobulins (g, a, m, d, e). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under SGG, 1 in the last five years. The average 510(k) review took 269 days (median 269); 269 days on average over the last three years.
Definition
The test system is intended for the (semi-)quantitative or quantitative determination of monoclonal immunoglobulins (M-proteins) and/or the identification of Immunoglobulin isotype of M-proteins in human specimens by mass spectrometric methods.
Classification
| Field | Value |
|---|---|
| Device name | Mass Spectrometric, Immunoglobulins (G, A, M, D, E) |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for SGG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 269 |
Compare with all 510(k) review times · Search every SGG clearance
Top SGG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site Group , Ltd. | 1 | 2025-10-17 |
Most recent SGG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250159 | The Binding Site Group , Ltd. | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | 2025-10-17 | 269 |
Recalls for SGG devices
openFDA lists no recalls for product code SGG.
Frequently asked questions
What is FDA product code SGG?
SGG is the FDA product code for mass spectrometric, immunoglobulins (g, a, m, d, e). It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is SGG?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGG?
Across 1 cleared submissions the average was 269 days from receipt to decision (median 269).
Which companies have the most SGG clearances?
The Binding Site Group , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SGG
- Run a recall and safety report across every SGG manufacturer
- Watch product code SGG 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times