510(k) K151502
K151502 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "ARCHITECT ROMA". The FDA issued a decision of Substantially Equivalent on April 28, 2016. The device falls under product code ONX (Ovarian Adnexal Mass Assessment Score Test System), a Class II device regulated under 21 CFR 866.6050. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2016
- Date Received
- June 4, 2015
- Clearance Type
- Traditional
- 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.