510(k) K112624

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 10, 2012

Date Received

September 8, 2011

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.