# K103676: Fujirebio Diagnostics Tumor Marker Control

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Jul 19, 2011 after 215 days
- Product code: OIU (Test, Epithelial Ovarian Tumor Associated Antigen (He4))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964020 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072939: HE4 Eia, Model: 404-10 US, Fujirebio Diagnostics,Inc. (2008) Summary page 1.

## Indications for use
The HE4 EIA is 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. For In Vitro Diagnostic Use Only. Fujireblo Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.

Source page: https://510kreport.com/device/K103676
Methodology: https://510kreport.com/methodology