510(k) · Cleared
Recalled · 2009Cellsearch 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 Feb 26, 2008 as substantially equivalent to K071729 (Veridex, LLC, 2007) after a 90-day review. Its family tree reaches back 4 generations to 2004. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 26, 2008
- 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). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- 3 generations backK050245 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2005 · Recalled
- 2 generations backK062013 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2006 · Recalled
- 1 generation backK071729 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2007
- This deviceK073338 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2008
- Descendant · cites it directly · 0 of its ownK103502 Cellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K103502Cellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC · 2010 · cites it directly0descendants
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 | K050245 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2005 | 1 |
| −2 | K062013 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2006 | 1 |
| −1 | K071729 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2007 | — |
| 0 (this device) | K073338 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2008 | — |
| +1 | K103502 | Cellsearch Circulating Tumor Cell Kit Model 7900001 | Veridex, LLC | 2010 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K071729 | Cellsearch Circulating Tumor Cell KitSummary page 2…Code NQI, Immunology Devices- 82 807.92 (a)(3): Identification of the legally marketed predicate device CellSearchT m Circulating Tumor Cell Kit, K071729 807.92 (a)(4): Device Description The CellSearchtm Circulating Tumor Cell Kit contains a ferrofluid-based capture reagent and… | 2007 |
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 |
|---|---|---|---|
| K103502 | Cellsearch Circulating Tumor Cell Kit Model 7900001 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2009 | Not classified | Z-0819-2010 | Other | Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit. Delayed detection of disease relapse or progression… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K103502 (Veridex, LLC, 2010) 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. 2008, 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 CellSearch™ Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearch™ Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal or prostate*…
Read the full statement (203 words)
The CellSearch™ Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.
The presence of CTC in the peripheral blood, as detected by the CellSearch™ Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal or prostate* cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast, colorectal or prostate cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast, colorectal and prostate cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
*Metastatic prostate cancer patients in this study were defined as having two consecutive increases in the serum marker PSA above a reference level, despite standard hormonal management. These patients are commonly described as having androgen-independent, hormone-resistant, or castration-resistant prostate cancer.
The CellSearch system includes: CellSave Preservative Tubes, the CellTracks® AutoPrep® System, the CellTracks® Analyzer II or the CellSpotter® Analyzer, and the CellSearch™ Circulating Tumor Cell Control Kit
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073338 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073338: Cellsearch Circulating Tumor Cell Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073338
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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