510(k) K103358
K103358 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "ROMA (HE4 EIA + ARCHITECT CA 125 II)". The FDA issued a decision of SESU on September 1, 2011. 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
- SESU ()
- Decision Date
- September 1, 2011
- Date Received
- November 16, 2010
- 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.