| Device |
cervical intraepithelial neoplasia (cin) test system |
| Regulation Description |
Cervical intraepithelial neoplasia (CIN) test system. |
| Definition |
The p16 CIN test system is a qualitative immunohistochemistry (IHC) test to assess the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues. It is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of CIN. Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information. |
| Physical State |
The device may include a primary antibody and accessory reagents or other detection system. |
| Technical Method |
The test uses a primary antibody, specific reagents or methods to detect p16INK4a protein in human clinical specimens. May include antibody-antigen protein complexes, which are visualized using an enzyme conjugated antibody or other detection systems or methods. |
| Target Area |
Human clinical specimens |
| Regulation Medical Specialty |
Pathology |
| Review Panel |
Pathology |
|---|
| Product Code | PRB |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.1865
|
|---|
| 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 |
Not Third Party Eligible |
