Ovarian Adnexal Mass Assessment Score Test System
The Ovarian Adnexal Mass Assessment Score Test System (product code ONX) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.6050 in the Obstetrics/Gynecology specialty (OB), cleared via 510(k) and reviewed by the Immunology panel. It measures one or more serum proteins to generate a single result indicating the likelihood that an adnexal pelvic mass is malignant in women for whom surgery is planned, serving as an adjunctive aid in a negative primary clinical and radiological evaluation to identify patients requiring oncology surgical expertise. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- ONX
- Device Class
- FDA class 2
- Regulation Number
- 866.6050
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K153607 | ROMA Calculation Tool Using Elecsys Assays | Jun 15, 2016 | Substantially Equivalent | Roche Diagnostics |
| K160090 | Lumipulse G ROMA | May 16, 2016 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K151502 | ARCHITECT ROMA | Apr 28, 2016 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K150588 | OVA1 Next Generation | Mar 18, 2016 | Substantially Equivalent | Vermillion, Inc. |
| K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) | Sep 01, 2011 | Unknown | Fujirebio Diagnostics,Inc. |
| DEN090004 | OVA1 TEST | Sep 11, 2009 | Unknown | Vermillion |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.