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510(k) K212176

CINtec Histology by Ventana Medical Systems, Inc. — Product Code PRB

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.

Other clearances by Ventana Medical Systems, Inc.

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  • K232879 — Roche Digital Pathology Dx (VENTANA DP 200) (June 14, 2024)
  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16 (October 27, 2017)
  • DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests) (March 4, 2017)
  • K142965 — Virtuoso System for IHC PR (1E2) using iScan HT (July 16, 2015)
  • K140465 — VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER (March 20, 2014)
  • K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI) (November 22, 2013)
  • K121516 — VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (September 26, 2013)

Other clearances for product code PRB

  • DEN160019 — CINtec Histology (50 tests), CINtec Histology (250 tests) (March 4, 2017)