Cervical Intraepithelial Neoplasia (cin) Test System
Device Code: 5028
Product Code(s):
PRB 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 (
Device Classification Information
| Device Type ID | 5028 |
| Device Name | Cervical Intraepithelial Neoplasia (cin) Test System |
| 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 |
| Target Area | Human Clinical Specimens |
| Regulation Description | Cervical Intraepithelial Neoplasia (CIN) Test System. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 864.1865 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PRB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 5028 |
| Device | Cervical Intraepithelial Neoplasia (cin) Test System |
| Product Code | PRB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cervical Intraepithelial Neoplasia (CIN) Test System. |
| CFR Regulation Number | 864.1865 [🔎] |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Ventana Medical Systems Inc | I | Sep-14-2018 |
TPLC Last Update: 2019-04-02 20:59:03