# K151378: Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Nov 24, 2015 after 186 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 6.

## Indications for use
For in vitro diagnostic use. Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of HE4 in human serum and plasma (lithium heparin or dipotassium EDTA) on the Lumipulse G System. 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 values should be used in conjunction with other clinical methods used for monitoring epithelial ovarian cancer. Lumipulse G HE4 Calibrators are for use in the calibration of the Lumipulse G System for the quantitative measurement of HE4 in human serum and plasma (lithium heparin or dipotassium EDTA).

Source page: https://510kreport.com/device/K151378
Methodology: https://510kreport.com/methodology