Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart G — Tumor Associated Antigen Immunological Test Systems](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems) → [21 CFR 866.6010](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6010) → OIU — Test, Epithelial Ovarian Tumor Associated Antigen (He4)

# OIU · Test, Epithelial Ovarian Tumor Associated Antigen (He4)

_Immunology · 21 CFR 866.6010 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU

## Overview

- **Product Code:** OIU
- **Device Name:** Test, Epithelial Ovarian Tumor Associated Antigen (He4)
- **Regulation:** [21 CFR 866.6010](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6010)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

## Classification Rationale

Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

## Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K151378](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU/K151378.md) | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | Fujirebio Diagnostics,Inc. | Nov 24, 2015 | SESE |
| [K112624](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU/K112624.md) | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 | Roche Diagnostics | Sep 10, 2012 | SESE |
| [K103676](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU/K103676.md) | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | Fujirebio Diagnostics,Inc. | Jul 19, 2011 | SESE |
| [K093957](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU/K093957.md) | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, | Fujirebio Diagnostics,Inc. | Mar 18, 2010 | SESE |
| [K072939](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU/K072939.md) | HE4 EIA, MODEL: 404-10 US | Fujirebio Diagnostics,Inc. | Jun 9, 2008 | SESE |

## Top Applicants

- Fujirebio Diagnostics,Inc. — 4 clearances
- Roche Diagnostics — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/OIU)

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