| Device |
test, epithelial ovarian tumor associated antigen (he4) |
| Regulation Description |
Tumor-associated antigen immunological test system. |
| 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. |
| 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 Medical Specialty |
Immunology |
| Review Panel |
Immunology |
|---|
| Product Code | OIU |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6010
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
