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
| Device Type ID | 3084 |
| Device Name | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Physical State | IVD |
| Technical Method | Dual-site Sandwich Enzyme Immunoassay Of Human Serum Or Plasma; May Be Measured By Stand-alone Spectrophotometer Or Automated Immunoassay Analyzer |
| Target Area | IVD |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OIU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3084 |
| Device | Test, Epithelial Ovarian Tumor Associated Antigen (he4) |
| Product Code | OIU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 1 |
False Negative Result | 1 |
| Total Device Problems | 2 |