510(k) · Cleared
Recalled · 2008Qca (Version 3.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cell Analysis, Inc. · NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Cleared on Feb 5, 2004 as substantially equivalent to K012138 (Chroma Vision Medical Systems, Inc., 2002) after a 281-day review. Its family tree reaches back 1 generation to 2002. It has been recalled once.
- Decided
- Feb 5, 2004
- Review
- 281 days
- Class
- Class II
- Product code
- NQN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012138 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK012138 Modification to Acis (Automated Cellular Imaging System)Chroma Vision Medical Systems, Inc. · 2002
- This deviceK031363 Qca (Version 3.1)Cell Analysis, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012138 | Modification to Acis (Automated Cellular Imaging System) | Chroma Vision Medical Systems, Inc. | 2002 | — |
| 0 (this device) | K031363 | Qca (Version 3.1) | Cell Analysis, Inc. | 2004 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012138 | Modification to Acis (Automated Cellular Imaging System)Summary page 1…America Device Establishment Registration Number: 9052602 Predicate Modification to ACIS (Automated Cellular Imaging System) Device k012138, September 30, 2002 ChromaVision Medical Systems, Inc. Capestrano, CA Submission May 29,… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2008 | Not classified | Z-1040-2009 | Software change control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All NQN devicesNQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NQN
427in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQN
1in 2023
MAUDE reports naming product code NQN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 427 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (161 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031363: Qca (Version 3.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031363
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026