Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5775](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5775) → OQZ — Anti-Mutated Citrullinated Vimentin Igg

# OQZ · Anti-Mutated Citrullinated Vimentin Igg

_Immunology · 21 CFR 866.5775 · Class 2_

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

## Overview

- **Product Code:** OQZ
- **Device Name:** Anti-Mutated Citrullinated Vimentin Igg
- **Regulation:** [21 CFR 866.5775](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5775)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K092399](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/OQZ/K092399.md) | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | Orgentec Diagnostika GmbH | Jul 1, 2010 | SESE |

## Top Applicants

- Orgentec Diagnostika GmbH — 1 clearance

---

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

**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