# DEN160019: CINtec Histology (50 tests), CINtec Histology (250 tests)

- Pathway: De Novo (Direct)
- Applicant: Ventana Medical Systems, Inc.
- Decided: Mar 4, 2017 after 285 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K212176: CINtec Histology (2021), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/DEN160019
Methodology: https://510kreport.com/methodology