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) → DAA — Igg, Peroxidase, Antigen, Antiserum, Control

# DAA · Igg, Peroxidase, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5510 · Class 2_

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

## Overview

- **Product Code:** DAA
- **Device Name:** Igg, Peroxidase, Antigen, Antiserum, Control
- **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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832675](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAA/K832675.md) | ANA MICROZYME TEST SYS #1610 | Clinical Sciences, Inc. | Sep 12, 1983 | SESE |
| [K831927](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAA/K831927.md) | ANTINUCLEAR ANTIBODY TEST KIT | Breit Laboratories, Inc. | Jul 18, 1983 | SESE |
| [K830005](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAA/K830005.md) | IP SPECIFIC G | Diagnostic Reagent Tech. | Jun 2, 1983 | SESE |
| [K822911](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAA/K822911.md) | ANAZYME ANA PEROXIDASE TEST SYSTEM | Clinical Sciences, Inc. | Oct 22, 1982 | SESE |
| [K791749](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAA/K791749.md) | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL | Clinical Sciences, Inc. | Oct 17, 1979 | SESE |

## Top Applicants

- Clinical Sciences, Inc. — 3 clearances
- Diagnostic Reagent Tech. — 1 clearance
- Breit Laboratories, Inc. — 1 clearance

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

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