K212176 is an FDA 510(k) clearance for the CINtec Histology. 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 Cleared decision on December 10, 2021, 151 days after receiving the submission on July 12, 2021.
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 | K212176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2021 |
| Decision Date | December 10, 2021 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| 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. |