OIUClass II

Test, Epithelial Ovarian Tumor Associated Antigen (He4)

21 CFR 866.6010 / Immunology

OIU is the FDA product code for Test, Epithelial Ovarian Tumor Associated Antigen (He4), a class II device type, regulated under 21 CFR 866.6010. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 5 510(k) clearances under this code, the most recent dated 2015-11-24, and no recalls.

Classification record

Product code: OIU
Device name: Test, Epithelial Ovarian Tumor Associated Antigen (He4)
FDA 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.
Regulation: 21 CFR 866.6010
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 5
Ingested recalls: 0

Clearances, product code OIU

By decision year

5 clearances under product code OIU with a decision year between 2008 and 2015, 2008 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OIU by decision year
Year	Clearances
2008	1
2010	1
2011	1
2012	1
2015	1

Applicants with the most clearances

Product code OIU

Applicants holding the most 510(k) clearances under product code OIU
Applicant	Clearances
Fujirebio Diagnostics, Inc.	4
Roche Diagnostics GmbH	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OIU

Recent recalls

Product code OIU

FDA records show no recalls under product code OIU.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)