# K032113: Acis (Automated Cellular Imaging System)

- Pathway: 510(k) (Traditional)
- Applicant: Chroma Vision Medical Systems, Inc.
- Decided: Dec 23, 2003 after 167 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
No predicates in its family tree.
13 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ChromaVision Medical Systems, Inc. ACIS - ER/PR SW Application: named in the summary without a submission number
- (no number) Human manual visualization by conventional microscopy: named in the summary without a submission number

## Most influential descendants
- K071671: Scanscope XT System (2007), 4 descendants of its own
- K080564: Scanscope XT System (2009), 3 descendants of its own
- K111543: Virtuoso (TM) System for Ihc HER2 (4B5) (2011), 2 descendants of its own
- K071128: Scanscope XT System (2007), 2 descendants of its own
- K141109: Aperio Epathology Eihc Ivd System (2014), 1 descendant of its own

## Indications for use
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape. In this software application the ACIS is intended for laboratory use as an accessory to the DakoCytomation HercepTest TM to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin embedded normal and neoplastic tissue. The ACIS is capable of detecting and quantifying regions of clinical interest in immunocytochemically stained material that would otherwise be appropriate for manual visualization by conventional microscopy. When used with the DakoCytomation HercepTestTM, it 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 ACIS score. The ACIS system is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscopic slides of breast cancer specimens stained for the presence of Her2 receptor protein. The accuracy of the test result depends upon the quality of immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in instructions for DakoCytomation HercepTestTM to assure the validity of the ACIS-assisted Her2 score. NOTE: All of the patients in the HERCEPTIN® clinical trials were selected using an investigational immunohistochemical clinical trial assay (CTA). None of the patients in those trials were selected using the DakoCytomation HercepTest TM. The DakoCytomation HercepTest TM was compared to the CTA on an independent set of samples and found to provide acceptably concordant results. The actual correlation of the DakoCytomation HercepTest TM to HERCEPTIN® clinical outcome has not been established.

Source page: https://510kreport.com/device/K032113
Methodology: https://510kreport.com/methodology