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) → CGM — Method, Immunodiffusion, Immunoglobulins (G, A, M)

# CGM · Method, Immunodiffusion, Immunoglobulins (G, A, M)

_Immunology · 21 CFR 866.5510 · Class 2_

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

## Overview

- **Product Code:** CGM
- **Device Name:** Method, Immunodiffusion, Immunoglobulins (G, A, M)
- **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K915650](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CGM/K915650.md) | HUMAN IGG SUBCLASS RID KIT | Janssen Biochimica | Mar 26, 1992 | SESE |
| [K920006](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CGM/K920006.md) | IL TEST IMMUNOGLOBULIN G (IGG) | Instrumentation Laboratory CO | Mar 13, 1992 | SESE |
| [K920370](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CGM/K920370.md) | ISOTYPES HUMAN IGG SUBCLASS EIA KIT | Isotypes, Inc. | Mar 11, 1992 | SESE |
| [K920008](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CGM/K920008.md) | IL TEST IMMUNOGLOBULIN M (IGM) | Instrumentation Laboratory CO | Mar 11, 1992 | SESE |

## Top Applicants

- Instrumentation Laboratory CO — 2 clearances
- Isotypes, Inc. — 1 clearance
- Janssen Biochimica — 1 clearance

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

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