Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart G — Tumor Associated Antigen Immunological Test Systems](/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems) → [21 CFR 866.6050](/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6050) → ONX — Ovarian Adnexal Mass Assessment Score Test System

# ONX · Ovarian Adnexal Mass Assessment Score Test System

_Obstetrics/Gynecology · 21 CFR 866.6050 · Class 2_

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

## Overview

- **Product Code:** ONX
- **Device Name:** Ovarian Adnexal Mass Assessment Score Test System
- **Regulation:** [21 CFR 866.6050](/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6050)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.

## Classification Rationale

Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document, see § 866.1(e).

## Special Controls

The device is classified as Class II under regulation 21 CFR 866.6050 with special controls. The special control guidance document, "Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System" accompanies this device.

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document,*see* § 866.1(e).(c)
*Black box warning.* Under section 520(e) of the Federal Food, Drug, and Cosmetic Act these devices are subject to the following restriction: A warning statement must be placed in a black box and must appear in all advertising, labeling, and promotional material for these devices. That warning statement must read:

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K153607](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/ONX/K153607.md) | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics | Jun 15, 2016 | SESE |
| [K160090](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/ONX/K160090.md) | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | May 16, 2016 | SESE |
| [K151502](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/ONX/K151502.md) | ARCHITECT ROMA | Fujirebio Diagnostics,Inc. | Apr 28, 2016 | SESE |
| [K150588](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/ONX/K150588.md) | OVA1 Next Generation | Vermillion, Inc. | Mar 18, 2016 | SESE |
| [K103358](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/ONX/K103358.md) | ROMA (HE4 EIA + ARCHITECT CA 125 II) | Fujirebio Diagnostics,Inc. | Sep 1, 2011 | SESU |
| [DEN090004](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/ONX/DEN090004.md) | OVA1 TEST | Vermillion | Sep 11, 2009 | DENG |

## Top Applicants

- Fujirebio Diagnostics,Inc. — 3 clearances
- Roche Diagnostics — 1 clearance
- Vermillion — 1 clearance
- Vermillion, Inc. — 1 clearance

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

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