DEN160019 is an FDA 510(k) submission for the CINtec Histology (50 tests), CINtec Histology (250 tests). This device is classified as a Cervical Intraepithelial Neoplasia (cin) Test System (Class II - Special Controls, product code PRB).
Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Not Cleared (DENG) decision on March 4, 2017.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1865. 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..
| 510(k) Number | DEN160019 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 23, 2016 |
| Decision Date | March 04, 2017 |
| Days to Decision | 285 days |
| Submission Type | Direct |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | PRB — Cervical Intraepithelial Neoplasia (cin) Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.1865 |
| 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. |