Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5400](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5400) → MGA — Alpha-1 Microglobulin, Antigen, Antiserum, Control

# MGA · Alpha-1 Microglobulin, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5400 · Class 1_

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

## Overview

- **Product Code:** MGA
- **Device Name:** Alpha-1 Microglobulin, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5400](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5400)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An alpha-globulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-globulin (a serum protein) in serum and other body fluids. Measurement of alpha-globulin may aid in the diagnosis of inflammatory lesions, infections, severe burns, and a variety of other conditions.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K965033](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MGA/K965033.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT | Beckman Instruments, Inc. | Apr 21, 1997 | SESE |
| [K933078](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MGA/K933078.md) | BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT | Beckman Instruments, Inc. | Jan 11, 1994 | SESE |

## Top Applicants

- Beckman Instruments, Inc. — 2 clearances

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

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