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) → DEN — Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control

# DEN · Alpha-1-T-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/DEN

## Overview

- **Product Code:** DEN
- **Device Name:** Alpha-1-T-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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K780325](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEN/K780325.md) | RID SYSTEM-HUMAN C-REACTIVE PROTEIN | Icl Scientific | Mar 17, 1978 | SESE |
| [K771879](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEN/K771879.md) | GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID | Hyland Therapeutic Div., Travenol Laboratories | Oct 19, 1977 | SESE |

## Top Applicants

- Icl Scientific — 1 clearance
- Hyland Therapeutic Div., Travenol Laboratories — 1 clearance

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

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