# Ovarian Adnexal Mass Assessment Score Test System
> **Product code: ONX** · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 866.6050
## Classification
- **FDA Product Code:** ONX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.6050
- **Review panel:** IM
- **Medical specialty:** Obstetrics/Gynecology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum.  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 isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ONX)
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