510(k) · Cleared
Recalled · 2007Cellsearch Circulating Tumor Cell Kit
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 Mar 15, 2005 as substantially equivalent to DEN040001 (Advanced Diagnostic Systems, 2004) after a 41-day review. Its family tree reaches back 1 generation to 2004. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 15, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- NQI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN040001 (2004). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- This deviceK050245 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2005
- Descendant · cites it directly · 3 of its ownK062013 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK071729 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2007
- Descendant · 3 generations on · 1 of its ownK073338 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2008 · Recalled
- Descendant · 4 generations on · 0 of its ownK103502 Cellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC · 2010 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K062013Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2006 · cites it directly3descendants
- K071729Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2007 · 2 generations on2descendants
- K073338Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2008 · 3 generations on1descendant
- K103502Cellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC · 2010 · 4 generations on0descendants
View 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) | K050245 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2005 | — |
| +1 | K062013 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2006 | 1 |
| +2 | K071729 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2007 | — |
| +3 | K073338 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2008 | 1 |
| +4 | K103502 | Cellsearch Circulating Tumor Cell Kit Model 7900001 | Veridex, LLC | 2010 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | 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 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062013 | Cellsearch Circulating Tumor Cell Kit | 2006 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2007 | Not classified | Z-1102-2007 | Other | An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results. |
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 CellSearchTM Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+ and cytokeratin 8 & 18+, and/or cytokeratin 19+) in whole blood in conjunction with the CellTracks® AutoPrep System, the CellSpotter® Analyzer or CellTracks® Analyzer II, and the CellSearchTM Circulating Tumor Cell Control Kit. The presence of CTC in the peripheral blood, as detected bythe CellSearchTM…
Read the full statement (112 words)
The CellSearchTM Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+ and cytokeratin 8 & 18+, and/or cytokeratin 19+) in whole blood in conjunction with the CellTracks® AutoPrep System, the CellSpotter® Analyzer or CellTracks® Analyzer II, and the CellSearchTM Circulating Tumor Cell Control Kit.
The presence of CTC in the peripheral blood, as detected bythe CellSearchTM Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. A CTC count of 5 or more per 7.5 mL of blood generally is predictive of shorter progression free survival and shorter overall survival.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050245 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050245: Cellsearch Circulating Tumor Cell Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050245
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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