510(k) · Cleared
Recalled · 2011Celltracks Analyer II
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 Dec 12, 2011 as substantially equivalent to K060110 (Immunicon Corp., 2006) after a 45-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 12, 2011
- Review
- 45 days
- Class
- Class II
- Product code
- NQI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN040001 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- 2 generations backK050145 Celltracka Analyzer IIImmunicon Corp. · 2005 · Recalled
- 1 generation backK060110 Celltracks Analyzer IIImmunicon Corp. · 2006 · Recalled
- This deviceK113181 Celltracks Analyer IIVeridex, LLC · 2011
- Descendant · cites it directly · 0 of its ownK130794 Celltracks Analyzer II SystemVeridex, LLC · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K130794Celltracks Analyzer II SystemVeridex, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN040001 | Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System | Advanced Diagnostic Systems | 2004 | — |
| −2 | K050145 | Celltracka Analyzer II | Immunicon Corp. | 2005 | 2 |
| −1 | K060110 | Celltracks Analyzer II | Immunicon Corp. | 2006 | 1 |
| 0 (this device) | K113181 | Celltracks Analyer II | Veridex, LLC | 2011 | — |
| +1 | K130794 | Celltracks Analyzer II System | Veridex, LLC | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K060110 | Celltracks Analyzer IISummary page 1…Product Code NQI) 4. Predicate device The predicate device is the CellTracks Analyzer HI® (K0601 10, March 16, 2006) 510(k) Summary, Continued 5. Device Description The CELLTRACKS ANALYZER II@ is a… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130794 | Celltracks Analyzer II System | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K130794 (Veridex, LLC, 2013) has gone furthest, with 0 descendants of its own.
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. 2011, 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 as stated in the FDA summary.
https://510kreport.com/device/K113181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113181: Celltracks Analyer II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113181
Report an extraction error
Are you the manufacturer?
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