# K092333: Pathiam System with Iscan for P53 and KI-67

- Pathway: 510(k) (Traditional)
- Applicant: Bioimagene, Inc.
- Decided: Oct 27, 2010 after 449 days
- Product code: NQN (Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity)
- 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: 1 generation back to K053520 (2006). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062428: Ventana Image Analysis System, Model Vias, Tripath Imaging, Inc. (2006) Summary page 3.
- K053520: Ventana Image Analysis System, Model KI-67, Tripath Imaging, Inc. (2006) Summary page 3.

## Most influential descendants
- K111755: Virtuoso System for Ihc KI-67 (30-9) (2012), 2 descendants of its own
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5) (2011), 2 descendants of its own
- K111872: Virtuoso System for Ihc P53 (DO-7) (2012), 1 descendant 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

## Indications for use
This device is intended for in vitro diagnostic (IVD) use. The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores. This instrument is intended for in-vitro diagnostic use only with those assays for which it has received FDA clearance. The iScan Slide Scanner System is designed to be used to scan and digitize microscope slides, and compress and view digitized images of microscope slides. If the Scanner is used in any way not specified in this manual, the protection provided by the equipment may be compromised. This device is intended for in vitro diagnostic (IVD) use. The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores. The Ki-67 application is intended as an aid to the pathologist to quantify the percentage of positively stained nuclei in formalin-fixed paraffin embedded normal and neoplastic breast tissue specimens immunohistochemically stained with Dako mouse monoclonal anti-human Ki-67 antigen, clone MI131 visualized with DAB chromogen as specified in the instructions for these reagents. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for Dako Ki-67 to assure the validity of the PATHIAM-assisted Ki-67 assessment. Ki-67 results provided by the PATHIAM System are indicated for use to assess proliferative activity when used with in vitro diagnostic reagents marketed for this indication. interpretation should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The pathologist must verify agreement with the PATHIAM score. This device is intended for in vitro diagnostic (IVD) use. The PATHIAM System is intended as an aid to the pathologist to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape, using appropriate controls to assure the validity of the scores. The p53 application is intended for use as an aid to the pathologist to quantify the percentage of positively stained nuclei in formialin fixed paraffin embedded breast tissue specimens stained with Dako mouse monoclonal anti-human p53 antibody, clone DO7and visualized with DAB. chromogen, to detect both wild-type and mutant p53, a nuclear protein, as specified in the instructions for these reagents. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for Dako p53 to assure the validity of the PATHIAM-assisted p53 assessment. The p53 results provided by the PATHIAM System are indicated for use for the identification of p53 accumulation in human neoplasias when used with IVD reagents marketed for this indication. Interpretation should be made within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist. The pathologist must verify agreement with the PATHIAM score.

Source page: https://510kreport.com/device/K092333
Methodology: https://510kreport.com/methodology