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) → DAE — Complement C9, Antigen, Antiserum, Control

# DAE · Complement C9, 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/DAE

## Overview

- **Product Code:** DAE
- **Device Name:** Complement C9, 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K150412](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K150412.md) | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator | The Binding Site Group , Ltd. | Aug 28, 2015 | SESE |
| [K113349](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K113349.md) | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO | The Binding Site Group , Ltd. | Jul 11, 2012 | SESE |
| [K992488](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K992488.md) | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | The Binding Site, Ltd. | Sep 17, 1999 | SESE |
| [K974111](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K974111.md) | QUIDEL CH50 EQ EIA | Quidel Corp. | Jul 29, 1998 | SESE |
| [K954145](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K954145.md) | WAKO AUTOKIT CH50 | Wako Chemicals USA, Inc. | Dec 18, 1995 | SESE |
| [K951639](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAE/K951639.md) | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | Incstar Corp. | Oct 13, 1995 | SESE |

## Top Applicants

- The Binding Site Group , Ltd. — 2 clearances
- Incstar Corp. — 1 clearance
- Quidel Corp. — 1 clearance
- The Binding Site, Ltd. — 1 clearance
- Wako Chemicals USA, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com