510(k) · Cleared
Recalled · Class II · 2022Cellsearch Circulating Tumor Cell Kit Model 7900001
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 21, 2010 as substantially equivalent to K073338 (Veridex, LLC, 2008) after a 22-day review. Its family tree reaches back 5 generations to 2004. It has been recalled 3 times.
- Decided
- Dec 21, 2010
- Review
- 22 days
- Class
- Class II
- Product code
- NQI
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN040001 (2004). No later device cites it as a predicate yet.
- Root · 5 generations backDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- 4 generations backK050245 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2005 · Recalled
- 3 generations backK062013 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2006 · Recalled
- 2 generations backK071729 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2007
- 1 generation backK073338 Cellsearch Circulating Tumor Cell KitVeridex, LLC · 2008 · Recalled
- This deviceK103502 Cellsearch Circulating Tumor Cell Kit Model 7900001Veridex, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN040001 | Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System | Advanced Diagnostic Systems | 2004 | — |
| −4 | K050245 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2005 | 1 |
| −3 | K062013 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2006 | 1 |
| −2 | K071729 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2007 | — |
| −1 | K073338 | Cellsearch Circulating Tumor Cell Kit | Veridex, LLC | 2008 | 1 |
| 0 (this device) | K103502 | Cellsearch Circulating Tumor Cell Kit Model 7900001 | Veridex, LLC | 2010 | — |
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 |
|---|---|---|---|
| * | K073338 | Cellsearch Circulating Tumor Cell KitSummary page 1…Code NQI) 4. Predicate device The predicate device is the CellSearchO Circulating Tumor Cell Kit (K073338, February 26, 2008) 510(k) Summary, Continued S. Device Description The CellSearchO Circulatin… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2022 | Class II | Z-1345-2022 | Process control | High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples |
| Apr 4, 2018 | Class II | Z-1530-2018 | Process design | Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results. |
| May 15, 2015 | Class II | Z-2406-2015 | Under Investigation by firm | Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
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. 2010, 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 (CD4S-, 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 (175 words)
The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD4S-, 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 metastaticb~east, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103502 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103502: Cellsearch Circulating Tumor Cell Kit Model 7900001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103502
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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