Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5240](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5240) → CZY — Complement C1s, Antigen, Antiserum, Control

# CZY · Complement C1s, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5240 · Class 2_

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

## Overview

- **Product Code:** CZY
- **Device Name:** Complement C1s, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5240](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5240)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K874379](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZY/K874379.md) | CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY | Cytotech, Inc. | Nov 25, 1987 | SESE |

## Top Applicants

- Cytotech, Inc. — 1 clearance

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

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