510(k) DEN090004
DEN090004 is an FDA 510(k) premarket notification submitted by Vermillion for the device "OVA1 TEST". The FDA issued a decision of De Novo Granted on September 11, 2009. The device falls under product code ONX (Ovarian Adnexal Mass Assessment Score Test System), a Class II device regulated under 21 CFR 866.6050. Vermillion has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 11, 2009
- Date Received
- July 22, 2009
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ovarian Adnexal Mass Assessment Score Test System
- Device Class
- Class II
- Regulation Number
- 866.6050
- Review Panel
- IM
- Submission Type
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.