510(k) · Cleared
Recalled · Class II · 2014Celltracka Analyzer II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunicon Corp. · NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Cleared on Mar 15, 2005 as substantially equivalent to DEN040001 (Advanced Diagnostic Systems, 2004) after a 50-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 15, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- NQI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN040001 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- This deviceK050145 Celltracka Analyzer IIImmunicon Corp. · 2005
- Descendant · cites it directly · 2 of its ownK060110 Celltracks Analyzer IIImmunicon Corp. · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK113181 Celltracks Analyer IIVeridex, LLC · 2011 · Recalled
- Descendant · 3 generations on · 0 of its ownK130794 Celltracks Analyzer II SystemVeridex, LLC · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN040001 | Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System | Advanced Diagnostic Systems | 2004 | — |
| 0 (this device) | K050145 | Celltracka Analyzer II | Immunicon Corp. | 2005 | — |
| +1 | K060110 | Celltracks Analyzer II | Immunicon Corp. | 2006 | 1 |
| +2 | K113181 | Celltracks Analyer II | Veridex, LLC | 2011 | 1 |
| +3 | K130794 | Celltracks Analyzer II System | Veridex, LLC | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | DEN040001 | Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System Our reading of the summary gave K031588, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040001, Cellsearch Epithelial Cell Enrichment Kit; Cellspotter… (Advanced Diagnostic Systems), granted Jan 21, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2004 |
| * | — | Veridex LLC CellSearch Epithelial Cell kit/Cell Spotter Analyzer Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060110 | Celltracks Analyzer II | 2006 | 2 |
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¿. |
| Aug 17, 2011 | Not classified | Z-1004-2012 | Software design | Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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 Immunicon CellTracks Analyzer II is a semi-automated fluorescence microscope
used to enumerate fluorescently labeled cells that are immuno-magnetically selected
and aligned. The system 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 as stated in the FDA summary.
https://510kreport.com/device/K050145 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050145: Celltracka Analyzer II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050145
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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