# K131140: Omnyx Idp for HER2 Manual Application

- Pathway: 510(k) (Traditional)
- Applicant: Omnyx, LLC
- Decided: Apr 1, 2014 after 344 days
- Product code: OEO (Automated Digital Image Manual Interpretation Microscope)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032113 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071671: Scanscope XT System, Aperio Technologies (2007) Summary page 5.
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5), Ventana Medical Systems, Inc. (2011) Summary page 4.

## Indications for use
The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for in vitro diagnostic use as an aid to pathology professionals for creating, managing, storing, annotating, measuring, and viewing digital Whole Slide Images (WSI) from formalin-fixed, paraffin-embedded (FFPE) tissue sections stained with the Dako HercepTest. The Omnyx Manual Read of the Digital HER2 Application on the Omnyx IDP System is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in digital images of FFPE breast cancer tissue immunohistochemically stained with the Dako HercepTest and viewed on a computer monitor. The Dako HercepTest is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.

Source page: https://510kreport.com/device/K131140
Methodology: https://510kreport.com/methodology