Test, Epithelial Ovarian Tumor Associated Antigen (He4)
The Test, Epithelial Ovarian Tumor Associated Antigen (HE4) is an enzyme immunometric assay for the quantitative measurement of HE4 (human epididymis protein 4) in human serum, intended as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, used in conjunction with other clinical monitoring methods. Classified as FDA Class 2 under regulation 21 CFR 866.6010 within the Immunology medical specialty, it requires a 510(k) premarket notification and is eligible for third-party review; it is not intended to assess initial risk or diagnose new disease. The product code is OIU. It is not flagged as an implant or life-sustaining device.
Research product code OIU in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OIU
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151378 | Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators | Nov 24, 2015 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K112624 | ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 | Sep 10, 2012 | Substantially Equivalent | Roche Diagnostics |
| K103676 | FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL | Jul 19, 2011 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K093957 | ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, | Mar 18, 2010 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K072939 | HE4 EIA, MODEL: 404-10 US | Jun 09, 2008 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.