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U.S. Department of Health and Human Services

Product Classification

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Device test, epithelial ovarian tumor associated antigen (he4)
Regulation Description Tumor-associated antigen immunological test system.
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.
Physical State IVD
Technical Method dual-site sandwich enzyme immunoassay of human serum or plasma; may be measured by stand-alone spectrophotometer or automated immunoassay analyzer
Target Area IVD
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOIU
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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