# K031363: Qca (Version 3.1)

- Pathway: 510(k) (Abbreviated)
- Applicant: Cell Analysis, Inc.
- Decided: Feb 5, 2004 after 281 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012138 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012138: Modification to Acis (Automated Cellular Imaging System), Chroma Vision Medical Systems, Inc. (2002) Summary page 1.

## Recalls of this device
- Nov 6, 2008 · Not classified · Z-1040-2009: A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.

## Indications for use
The QCA device is intended to detect and classify cells of clinical interest based on recognition of cellular areas of particular color and chromatic intensity. In this software application, the QCA device is intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications. The QCA 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 estrogen (ER) nuclear 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 to assure the validity of the QCA ER scores.

Source page: https://510kreport.com/device/K031363
Methodology: https://510kreport.com/methodology