Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5420](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5420) → DEX — Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

# DEX · Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5420 · Class 1_

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

## Overview

- **Product Code:** DEX
- **Device Name:** Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5420](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5420)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

## 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K823765](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K823765.md) | ANTI SERA TO HUMAN OROSCOMUCOID | Kent Laboratories, Inc. | Dec 30, 1982 | SESE |
| [K801909](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K801909.md) | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | J.T. Baker Chemical Co. | Sep 26, 1980 | SESE |
| [K791341](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K791341.md) | HUMAN ALPHA, ACID GLYCOPROTEIN | Beckman Instruments, Inc. | Aug 16, 1979 | SESE |
| [K781023](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K781023.md) | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | Icl Scientific | Aug 14, 1978 | SESE |
| [K760143](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K760143.md) | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Oxford Laboratories, Inc. | Jul 20, 1976 | SESE |

## Top Applicants

- Beckman Instruments, Inc. — 1 clearance
- Icl Scientific — 1 clearance
- J.T. Baker Chemical Co. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance
- Oxford Laboratories, Inc. — 1 clearance

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

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