Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5090](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5090) → NUM — Autoantibodies, Nuclear Body Protein, Sp100

# NUM · Autoantibodies, Nuclear Body Protein, Sp100

_Immunology · 21 CFR 866.5090 · Class 2_

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

## Overview

- **Product Code:** NUM
- **Device Name:** Autoantibodies, Nuclear Body Protein, Sp100
- **Regulation:** [21 CFR 866.5090](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5090)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050662](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/NUM/K050662.md) | QUANTA LITE SP100 ELISA | Inova Diagnostics, Inc. | Jun 13, 2005 | SESE |

## Top Applicants

- Inova Diagnostics, Inc. — 1 clearance

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

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