Device |
chromogranin a |
Regulation Description |
Tumor-associated antigen immunological test system. |
Definition |
In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors. |
Physical State |
Immunofluorescent reagents, monoclonal antibody conjugated with cryptate, monoclonal antibody conjugated with Alexa Fluor 647 |
Technical Method |
Immunofluorescent assay |
Target Area |
Venous blood serum, but other specimen types may be possible |
Regulation Medical Specialty |
Immunology |
Review Panel |
Immunology |
Product Code | QXS |
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 |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |