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) → KTP — Complement C3b Activator Immunoassay Reagents

# KTP · Complement C3b Activator Immunoassay Reagents

_Immunology · 21 CFR 866.5260 · Class 2_

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

## Overview

- **Product Code:** KTP
- **Device Name:** Complement C3b Activator Immunoassay Reagents
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K790059](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTP/K790059.md) | PROACTIVATOR C3, C4 AND C3 | Icl Scientific | Mar 15, 1979 | SESE |

## Top Applicants

- Icl Scientific — 1 clearance

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

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