| Device |
immunocytochemistry assay, p16/ki-67 |
| Regulation Description |
Immunohistochemistry reagents and kits. |
| Definition |
The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician. |
| Physical State |
The device includes a monoclonal or polyclonal primary antibody(ies) 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(ies) to detect the presence of expressed antigen(s) protein(s) in cytologic preparations such as smears, liquid-based slide preparations and cytospin preparation slides. Antibody-antigen complexes are visualized using enzyme conjugated primary or secondary antibody(ies) to catalyze a color-producing reaction |
| Target Area |
Cytologic slide preparations of human cytologic specimens |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Pathology |
|---|
| Product Code | QKF |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
PMA
|
|---|
| Regulation Number |
864.1860
|
|---|
| 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 |
