Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) → SGG — Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

# SGG · Mass Spectrometric, Immunoglobulins (G, A, M, D, E)

_Immunology · 21 CFR 866.5510 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SGG

## Overview

- **Product Code:** SGG
- **Device Name:** Mass Spectrometric, Immunoglobulins (G, A, M, D, E)
- **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250159](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SGG/K250159.md) | Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser | The Binding Site Group , Ltd. | Oct 17, 2025 | SESE |

## Top Applicants

- The Binding Site Group , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SGG](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SGG)

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