OIU
5 FDA 510(k) clearances · Product code
215 daysmedian time to decision
368 days90th percentile
5clearances measured
FDA profile
- Official device name
- Test, Epithelial Ovarian Tumor Associated Antigen (He4)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators (K151378) | Fujirebio Diagnostics,Inc. | 2015-11-24 |
| ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 (K112624) | Roche Diagnostics | 2012-09-10 |
| FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL (K103676) | Fujirebio Diagnostics,Inc. | 2011-07-19 |
| ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, (K093957) | Fujirebio Diagnostics,Inc. | 2010-03-18 |
| HE4 EIA, MODEL: 404-10 US (K072939) | Fujirebio Diagnostics,Inc. | 2008-06-09 |
Track OIU automatically
Every clearance here is in the API, with alerts when new ones post.