510(k) · Cleared
Recalled · 2010Cellsearch Epithelial Cell Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veridex, LLC · NRS Control Material, Blood Circulating Epithelial Cancer Cell
Cleared on Jun 28, 2004 as substantially equivalent to DEN040001 (Advanced Diagnostic Systems, 2004) after an 83-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.
- Decided
- Jun 28, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- NRS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN040001 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backDEN040001 Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004
- This deviceK040898 Cellsearch Epithelial Cell Control KitVeridex, LLC · 2004
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) | K040898 | Cellsearch Epithelial Cell Control Kit | Veridex, LLC | 2004 | — |
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 NRS? 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?
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 |
|---|---|---|---|---|
| Nov 9, 2010 | Not classified | Z-1472-2011 | Process control | There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN040001.
How does its category compare?
All NRS devicesNRS Control Material, Blood Circulating Epithelial Cancer Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NRS
FDA has decided no NRS device since 2007.
Median 510(k) review, days · NRS
Too few NRS 510(k)s in any year since 2007 to give a median.
Recalls per year · NRS
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NRS
No MAUDE report names NRS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 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 CeliSearch™ Epithelial Cell Control kit is intended for use as an assayed control, when performing the CeliSearch™ Epithelial Cell Kit on the CellTracks® AutoPrep System, to ensure that the sample detection and identification systems are working.
For in vitro diagnostic use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K040898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040898: Cellsearch Epithelial Cell Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040898
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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