510(k) K093957
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2010
- Date Received
- December 23, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Epithelial Ovarian Tumor Associated Antigen (He4)
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type
An enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is not intended to estimate or assess the risk of disease outcomes of patients.