# K112624: Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 10, 2012 after 368 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: 4 generations back to K964020 (1997). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093957: Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 SP54-01,, Fujirebio Diagnostics,Inc. (2010)
- (no number) Elecsys hGH CalSet: named in the summary without a submission number
- (no number) Elecsys PreciControl Multimarker: named in the summary without a submission number
- (no number) Elecsys DHEA-S CalCheck 5: named in the summary without a submission number

## Most influential descendants
- K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (2016), 1 descendant of its own
- K250925: ADVIA Centaur Cytokeratin Fragment 21-1 (2025), 0 descendants of its own

## Indications for use
The Elecsys HE4 assay is an immunoassay for the quantitative determination of HE4 in human serum and plasma. The assay is 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 findings used for monitoring ovarian cancer. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys HE4 CalSet is used for calibrating the quantitative Elecsys HE4 assay on the Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl HE4 is used for quality control of the Elecsys HE4 immunoassay on Elecsys and cobas e immunoassay analyzers. The Elecsys HE4 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys HE4 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K112624
Methodology: https://510kreport.com/methodology