# K031715: Ariol Her-2/Neu Ihc

- Pathway: 510(k) (Traditional)
- Applicant: Applied Imaging Corp.
- Decided: Jan 8, 2004 after 220 days
- Product code: NOT (Microscope, Automated, Image Analysis, Operator Intervention)
- Device class: 2
- Regulation: 21 CFR 864.1860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080564: Scanscope XT System (2009), 3 descendants of its own
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5) (2011), 2 descendants of its own
- K140957: Genasis Hipath Ihc Family (2015), 0 descendants of its own
- K131140: Omnyx Idp for HER2 Manual Application (2014), 0 descendants of its own

## Recalls of this device
- May 6, 2016 · Class III · Z-1948-2016: An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.

## Indications for use
The Applied Imaging AriolTM is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation. When used with DAKO HercepTest, it is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. Note: The actual correlation of the DAKO HercepTest to Herceptin clinical outcome has not been established. The Ariol system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.

Source page: https://510kreport.com/device/K031715
Methodology: https://510kreport.com/methodology