Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5530](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5530) → DAS — Igg (Fc Fragment Specific), Antigen, Antiserum, Control

# DAS · Igg (Fc Fragment Specific), Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5530 · Class 1_

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

## Overview

- **Product Code:** DAS
- **Device Name:** Igg (Fc Fragment Specific), Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5530](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5530)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An immunoglobulin G (Fc fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fc (carbohydrate containing) fragment of immunoglobulin G (resulting from breakdown of immunoglobulin G antibodies) in urine, serum, and other body fluids. Measurement of immunoglobulin G Fc fragments aids in the diagnosis of plasma cell antibody-forming abnormalities, e.g., gamma heavy chain disease.

## 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 the limitations in § 866.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K982023](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K982023.md) | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT | Inova Diagnostics, Inc. | Sep 4, 1998 | SESE |
| [K944876](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K944876.md) | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT | Research Diagnostics, Inc. | Dec 15, 1994 | SESE |
| [K943205](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K943205.md) | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) | Research Diagnostics, Inc. | Sep 7, 1994 | SESE |
| [K943098](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K943098.md) | HUMAN IGG SUBCLASSES ELISA COMBI KIT | Research Diagnostics, Inc. | Sep 7, 1994 | SESE |
| [K895600](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K895600.md) | HUMAN (IGG) SUBCLASS (EIA) KIT | The Binding Site, Ltd. | Nov 8, 1989 | SESE |
| [K790708](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K790708.md) | ANTISERUM TO HUMAN IG G FC FRAGMENTS | Kent Laboratories, Inc. | Aug 22, 1979 | SESE |
| [K790715](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K790715.md) | ANTISERUM TO HUMAN FC | Kent Laboratories, Inc. | Aug 16, 1979 | SESE |
| [K761156](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAS/K761156.md) | AMINOGLYCOSIDE CONTROLS | Supelco, Inc. | Dec 9, 1976 | SESE |

## Top Applicants

- Research Diagnostics, Inc. — 3 clearances
- Kent Laboratories, Inc. — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- Supelco, Inc. — 1 clearance
- Inova Diagnostics, Inc. — 1 clearance

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

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