Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5260](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5260) → DAC — Complement C3b Activator, Antigen, Antiserum, Control

# DAC · Complement C3b Activator, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5260 · Class 2_

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

## Overview

- **Product Code:** DAC
- **Device Name:** Complement C3b Activator, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5260](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5260)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A complement C3b inactivator immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C3b inactivator (a plasma protein) in serum. Complement is a group of serum proteins that destroy infectious agents. Measurement of complement C3b inactivator aids in the diagnosis of inherited antibody dysfunction.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K891904](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAC/K891904.md) | EZ COMPLEMENT C1 | Diamedix Corp. | Apr 14, 1989 | SESE |
| [K771583](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAC/K771583.md) | FLUORESCENT ANTI. ANTI-HUMAN C3 | Burroughs Wellcome Co. | Sep 2, 1977 | SESE |

## Top Applicants

- Diamedix Corp. — 1 clearance
- Burroughs Wellcome Co. — 1 clearance

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

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