SGG · Class II · 21 CFR 866.5510

FDA Product Code SGG: Mass Spectrometric, Immunoglobulins (g, A, M, D, E)

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.

Leading manufacturers include The Binding Site Group , Ltd..

1
Total
1
Cleared
269d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Mass Spectrometric, Immunoglobulins (g, A, M, D, E) Devices (Product Code SGG)

1 devices
1–1 of 1
Cleared Oct 17, 2025
Immunoglobulin Isotypes (GAM) for the EXENT Analyser
K250159
The Binding Site Group , Ltd.
Immunology · 269d

About Product Code SGG - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SGG since 2025, with 1 receiving FDA clearance (average review time: 269 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SGG devices are reviewed by the Immunology panel. Browse all Immunology devices →