| Device |
immunohistochemistry assay, antibody, ki-67 |
| Definition |
The Ki-67 antibody is a qualitative immunohistochemical antibody intended to identify Ki-67 protein expression in human clinical tissue specimens. The KI-67 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs. |
| Physical State |
The device includes a monoclonal primary antibody and accessory reagents, including secondary antibodies, buffers, substrates, and counterstains. The device may be intended for manual or automated staining methods. |
| Technical Method |
The test uses a primary monoclonal antibody to detect the presence of expressed antigen protein in fixed tissue specimens. Antibody-antigen complexes are visualized using an enzyme conjugated primary or secondary antibody to catalyze a color-producing reaction. |
| Target Area |
Formalin-fixed paraffin-embedded (FFPE) Human clinical tissue specimens. |
| Review Panel |
Pathology |
|---|
| Product Code | QQT |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| 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 |
