ONX — Ovarian Adnexal Mass Assessment Score Test System Class II
FDA product code ONX covers "Ovarian Adnexal Mass Assessment Score Test System", a Class II medical device regulated under 21 CFR 866.6050. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ONX
- Device Class
- Class II
- Regulation Number
- 866.6050
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153607 | roche diagnostics | ROMA Calculation Tool Using Elecsys Assays | June 15, 2016 |
| K160090 | fujirebio diagnostics | Lumipulse G ROMA | May 16, 2016 |
| K151502 | fujirebio diagnostics | ARCHITECT ROMA | April 28, 2016 |
| K150588 | vermillion | OVA1 Next Generation | March 18, 2016 |
| K103358 | fujirebio diagnostics | ROMA (HE4 EIA + ARCHITECT CA 125 II) | September 1, 2011 |
| DEN090004 | vermillion | OVA1 TEST | September 11, 2009 |