# P190024: CINtec PLUS Cytology

- Pathway: PMA
- Applicant: Ventana Medical Systems, Inc.
- Decided: Mar 10, 2020 after 180 days
- Product code: QKF (Immunocytochemistry Assay, P16/Ki-67)
- Device class: 3
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

Source page: https://510kreport.com/device/P190024
Methodology: https://510kreport.com/methodology