OIU

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Product code

OIU

Device name

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Device class

Class 2

21 CFR

21 CFR 866.6010

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).