Test, Epithelial Ovarian Tumor Associated Antigen (he4)
Immunology · 21 CFR 866.6010
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.
Recent MDR events
11 adverse event reports on file
- ELECSYS HE4 ASSAYJun 16, 2026MalfunctionRoche Diagnostics1823260-2026-02384
- ELECSYS HE4Mar 18, 2026MalfunctionRoche Diagnostics1823260-2026-00983
- ARCHITECT HE4 REAGENT KITFeb 6, 2026MalfunctionAbbott Gmbh3002809144-2026-00026
- ELECSYS HE4 ASSAYJul 9, 2025MalfunctionRoche Diagnostics1823260-2025-02095
- ELECSYS HE4Jul 12, 2024MalfunctionRoche Diagnostics1823260-2024-02005
- ELECSYS HE4Dec 20, 2023MalfunctionRoche Diagnostics1823260-2023-04145
- ALINITY I HE4 REAGENT KITJul 1, 2022MalfunctionAbbott Gmbh3002809144-2022-00227
- ELECSYS HE4 ASSAYJan 18, 2022MalfunctionRoche Diagnostics1823260-2022-00140
- ARCHITECT HE4Jan 14, 2019MalfunctionAbbott Germany3002809144-2019-00011
- ARCHITECT HE4Jun 9, 2016MalfunctionAbbott Germany3002809144-2016-00035
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Fujirebio Diagnostics,Inc.Nov 24, 2015
K151378 · Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators
- Roche DiagnosticsSep 10, 2012
K112624 · ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5
- Fujirebio Diagnostics,Inc.Jul 19, 2011
K103676 · FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
- Fujirebio Diagnostics,Inc.Mar 18, 2010
K093957 · ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
- Fujirebio Diagnostics,Inc.Jun 9, 2008
K072939 · HE4 EIA, MODEL: 404-10 US