# Test, Epithelial Ovarian Tumor Associated Antigen (He4)
> **Product code: OIU** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6010
## Classification
- **FDA Product Code:** OIU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.6010
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OIU)
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