OIU — Test, Epithelial Ovarian Tumor Associated Antigen (He4) Class II
Classification Details
- Product Code
- OIU
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K151378 | fujirebio diagnostics | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | November 24, 2015 |
| K112624 | roche diagnostics | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK | September 10, 2012 |
| K103676 | fujirebio diagnostics | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | July 19, 2011 |
| K093957 | fujirebio diagnostics | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2 | March 18, 2010 |
| K072939 | fujirebio diagnostics | HE4 EIA, MODEL: 404-10 US | June 9, 2008 |