# K080910: Pathiam System for HER2/Neu Immunohistochemistry Reagents & Kits

- Pathway: 510(k) (Traditional)
- Applicant: Bioimagene, Inc.
- Decided: Feb 4, 2009 after 309 days
- Product code: NOT (Microscope, Automated, Image Analysis, Operator Intervention)
- 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: 2 generations back to K032113 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062756: Pathiam Imaging Software for HER2/Neu, Bioimagene, Inc. (2007) Summary page 2.

## Indications for use
PATHIAM-Assisted Scoring: Intended for clinical laboratory use as an accessory to the DAKO HercepTest to aid in the detection and semi-quantitative measurement of Her2/neu in form ain fixed, paraffin-embedded normal and neoplastic tissue. When used with the DAKO HercepTest, Pathiam Assisted Scoring is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN (Trastuzumab) treatment is being considered. The pathologist should verify agreement with the PATHIAM System score. HER2/neu results are indicated for use as an aid in the management, prognosis and predication of therapy outcomes of breast cancer. Note: The actual correlation of the DAKO HercepTest to Herceptin® clinical outcome has not been established.

Source page: https://510kreport.com/device/K080910
Methodology: https://510kreport.com/methodology