# K130021: Philips Herceptest Digital Score

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Sep 19, 2013 after 259 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111914: Virtual Slide System, Olympus VS800 System, Olympus America Inc. / Scientific Equipment Group (2012) Summary page 1.
- K071671: Scanscope XT System, Aperio Technologies (2007) Summary page 1.

## Indications for use
The Philips HER2/neu IHC Digital Manual Read is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The Philips HER2/neu IHC Digital Manual Read is based on the Philips Digital Pathology Solution platform, which is an automated digital slide creation, management, viewing and analysis system. The Philips HER2/neu IHC Digital Manual Read is intended for use as an accessory to the Dako HercepTest to aid in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded neoplastic tissue immunohistochemically stained for HER-2 receptors on a computer monitor. When used with the Dako HercepTest it is indicated for use as an aid in the assessment of breast cancer patients from whom HERCEPTIN® (Trastuzumab), PERJETA® (Pertuzumab) or KADCYLA® (Ado-Trastuzumab Emtansine) treatment is being considered. Note: The actual correlation of the Dako HercepTest to Herceptin®, Perjeta®, or Kadcyla®, clinical outcome has not been established. Note: The Philips HER2/neu IHC Digital Manual Read is for evaluation of digital images of immunohistochemically stained slides that would otherwise be appropriate for manual visualization by conventional microscopy. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for Dako HercepTest to assure the validity of the scores obtained using Philips HER2/neu IHC Digital Manual Read.

Source page: https://510kreport.com/device/K130021
Methodology: https://510kreport.com/methodology