De Novo · Granted
GrantedCellsearch Epithelial Cell Enrichment Kit; Cellspotter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Diagnostic Systems · NQI System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Granted on Jan 21, 2004 as a new device type through De Novo after a 19-day review. 10 later devices descend from it.
- Decided
- Jan 21, 2004
- Review
- 19 days
- Class
- Class II
- Product code
- NQI
- Recalls
- None
10 later devices descend from it, 3 citing it directly.
- This deviceDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- Descendant · cites it directly · 4 of its ownK050245 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK062013 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2006 · Recalled
- Descendant · cites it directly · 3 of its ownK050145 Celltracka Analyzer IIImmunicon Corp. · 2005 · Recalled
- Descendant · 3 generations on · 2 of its ownK071729 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2007
- Descendant · 2 generations on · 2 of its ownK060110 Celltracks Analyzer IIImmunicon Corp. · 2006 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K050245Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2005 · cites it directly4descendants
- K062013Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2006 · 2 generations on3descendants
- K050145Celltracka Analyzer IIImmunicon Corp. · 2005 · cites it directly3descendants
- K071729Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2007 · 3 generations on2descendants
- K060110Celltracks Analyzer IIImmunicon Corp. · 2006 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN040001 | Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System | Advanced Diagnostic Systems | 2004 | — |
| +1 | K050245 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2005 | 1 |
| +2 | K062013 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2006 | 1 |
| +1 | K050145 | Celltracka Analyzer II | Immunicon Corp. | 2005 | 2 |
| +3 | K071729 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2007 | — |
| +2 | K060110 | Celltracks Analyzer II | Immunicon Corp. | 2006 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050245 (Veridex, LLC, 2005) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/DEN040001 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN040001: Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN040001
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026