510(k) K212176
K212176 is an FDA 510(k) premarket notification submitted by Ventana Medical Systems, Inc. for the device "CINtec Histology". The FDA issued a decision of Substantially Equivalent on December 10, 2021. The device falls under product code PRB (Cervical Intraepithelial Neoplasia (Cin) Test System), a Class II device regulated under 21 CFR 864.1865. Ventana Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2021
- Date Received
- July 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cervical Intraepithelial Neoplasia (Cin) Test System
- Device Class
- Class II
- Regulation Number
- 864.1865
- Review Panel
- PA
- Submission Type
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.