# K212176: CINtec Histology

- Pathway: 510(k) (Traditional)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Dec 10, 2021 after 151 days
- Product code: PRB (Cervical Intraepithelial Neoplasia (Cin) Test System)
- Device class: 2
- Regulation: 21 CFR 864.1865
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160019 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160019: CINtec Histology (50 tests), CINtec Histology (250 tests), Ventana Medical Systems, Inc. (2017) Summary page 4.

## Indications for use
CINtec® Histology is a qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information. Intended for in vitro diagnostic (IVD) use.

Source page: https://510kreport.com/device/K212176
Methodology: https://510kreport.com/methodology