510(k) · Cleared
Recalled · Class II · 2014Celltracks Analyzer II System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veridex, LLC · NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Cleared on Jun 20, 2013 as substantially equivalent to K113181 (Veridex, LLC, 2011) after a 90-day review. Its family tree reaches back 4 generations to 2004. It has been recalled once.
- Decided
- Jun 20, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- NQI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN040001 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- 3 generations backK050145 Celltracka Analyzer IIImmunicon Corp. · 2005 · Recalled
- 2 generations backK060110 Celltracks Analyzer IIImmunicon Corp. · 2006 · Recalled
- 1 generation backK113181 Celltracks Analyer IIVeridex, LLC · 2011 · Recalled
- This deviceK130794 Celltracks Analyzer II SystemVeridex, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN040001 | Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System | Advanced Diagnostic Systems | 2004 | — |
| −3 | K050145 | Celltracka Analyzer II | Immunicon Corp. | 2005 | 2 |
| −2 | K060110 | Celltracks Analyzer II | Immunicon Corp. | 2006 | 1 |
| −1 | K113181 | Celltracks Analyer II | Veridex, LLC | 2011 | 1 |
| 0 (this device) | K130794 | Celltracks Analyzer II System | Veridex, LLC | 2013 | — |
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 NQI? 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 |
|---|---|---|---|
| * | K113181 | Celltracks Analyer IISummary page 2…and report results remotely. Comparison to Predicate Device The CELLTRACKS ANALYZER 11®(modified) is substantially equivalent to the CELLTRACKS ANALYZER 11® (current - K113181, December 12, 2011). There has been no change to intended use, fundamental scientific technology, mode of operations, or specimen… | 2011 |
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 |
|---|---|---|---|---|
| Jan 8, 2014 | Class II | Z-1195-2014 | Device Design | Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
How does its category compare?
All NQI devicesNQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NQI
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · NQI
Too few NQI 510(k)s in any year since 2007 to give a median.
Recalls per year · NQI
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQI
3in 2008
MAUDE reports naming product code NQI, 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 | — | 0 | 3 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product is for in vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130794: Celltracks Analyzer II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130794
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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