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) → DAY — Complement C5, Antigen, Antiserum, Control

# DAY · Complement C5, 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/DAY

## Overview

- **Product Code:** DAY
- **Device Name:** Complement C5, 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K942326](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY/K942326.md) | HUMAN C5 RID KITS | Jay H. Geller | Aug 24, 1995 | SESE |
| [K950102](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY/K950102.md) | HUMAN C-5 RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | Apr 10, 1995 | SESE |
| [K772075](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAY/K772075.md) | RADIAL IMMUNODIFFUSION KIT-COMPLEMENT | Gelman Instrument Co. | Feb 3, 1978 | SESE |

## Top Applicants

- Kent Laboratories, Inc. — 1 clearance
- Jay H. Geller — 1 clearance
- Gelman Instrument Co. — 1 clearance

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

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