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) → KTO — Reagent, Immunoassay, Igg

# KTO · Reagent, Immunoassay, Igg

_Immunology · 21 CFR 866.5530 · Class 1_

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

## Overview

- **Product Code:** KTO
- **Device Name:** Reagent, Immunoassay, Igg
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K894416](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTO/K894416.md) | RAICHEM(TM) SPIA(TM) IGG REAGENTS | Reagents Applications, Inc. | Aug 1, 1989 | SESE |
| [K854483](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTO/K854483.md) | KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT | Kallestad Laboratories, Inc. | Dec 11, 1985 | SESE |

## Top Applicants

- Reagents Applications, Inc. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance

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

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