Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) → KTS — Second Antibody (Species Specific Anti-Animal Gamma Globulin)

# KTS · Second Antibody (Species Specific Anti-Animal Gamma Globulin)

_Immunology · 21 CFR 866.5510 · Class 2_

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

## Overview

- **Product Code:** KTS
- **Device Name:** Second Antibody (Species Specific Anti-Animal Gamma Globulin)
- **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K813508](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS/K813508.md) | SAC-CEL | Burroughs Wellcome Co. | Dec 29, 1981 | SESE |
| [K792637](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS/K792637.md) | CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) | Union Carbide Corp. | Jan 11, 1980 | SESE |
| [K792636](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS/K792636.md) | CENTRIA RADIOIMMUNOASSAY SEPARATION | Union Carbide Corp. | Jan 11, 1980 | SESE |
| [K781070](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS/K781070.md) | SECOND ANTIBODY | Pcl-Ria, Inc. | Aug 10, 1978 | SESE |

## Top Applicants

- Union Carbide Corp. — 2 clearances
- Burroughs Wellcome Co. — 1 clearance
- Pcl-Ria, Inc. — 1 clearance

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

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