Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5620](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5620) → DEB — Alpha-2-Macroglobulin, Antigen, Antiserum, Control

# DEB · Alpha-2-Macroglobulin, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5620 · Class 2_

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

## Overview

- **Product Code:** DEB
- **Device Name:** Alpha-2-Macroglobulin, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5620](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5620)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.

## Classification Rationale

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

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K140664](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K140664.md) | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | Apr 16, 2014 | SESE |
| [K081249](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K081249.md) | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Dade Behring, Inc. | Jul 21, 2008 | SESE |
| [K053073](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K053073.md) | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | Dade Behring, Inc. | Mar 28, 2006 | SESE |
| [K974564](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K974564.md) | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Beckman Instruments, Inc. | Feb 17, 1998 | SESE |
| [K914389](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K914389.md) | ALPHA-2 MACROGLOBULIN TEST RID KIT | The Binding Site, Ltd. | Dec 20, 1991 | SESE |
| [K896483](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K896483.md) | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Dec 1, 1989 | SESE |
| [K850683](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K850683.md) | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | Kent Laboratories, Inc. | Nov 27, 1985 | SESE |
| [K851282](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K851282.md) | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | Cooper Biomedical, Inc. | May 24, 1985 | SESE |
| [K850603](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K850603.md) | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | Applications Lab | Mar 5, 1985 | SESE |
| [K812493](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K812493.md) | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO | Dako Corp. | Sep 23, 1981 | SESE |
| [K791340](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K791340.md) | HUMAN ALPHA2 MACROGLOBULIN | Beckman Instruments, Inc. | Aug 16, 1979 | SESE |
| [K772246](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K772246.md) | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | Kallestad Laboratories, Inc. | Dec 22, 1977 | SESE |
| [K771780](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEB/K771780.md) | LAS-R TM | Hyland Therapeutic Div., Travenol Laboratories | Oct 4, 1977 | SESE |

## Top Applicants

- Dade Behring, Inc. — 2 clearances
- Beckman Instruments, Inc. — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- The Binding Site Group , Ltd. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance

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

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