# K050245: Cellsearch Circulating Tumor Cell Kit

- Pathway: 510(k) (Traditional)
- Applicant: Veridex, LLC
- Decided: Mar 15, 2005 after 41 days
- Product code: NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration)
- Device class: 2
- Regulation: 21 CFR 866.6020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN040001 (2004). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040001: Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System, Advanced Diagnostic Systems (2004). 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.

## Most influential descendants
- K062013: Cellsearch Circulating Tumor Cell Kit (2006), 3 descendants of its own
- K071729: Cellsearch Circulating Tumor Cell Kit (2007), 2 descendants of its own
- K073338: Cellsearch Circulating Tumor Cell Kit (2008), 1 descendant of its own
- K103502: Cellsearch Circulating Tumor Cell Kit Model 7900001 (2010), 0 descendants of its own

## Recalls of this device
- Apr 17, 2007 · Not classified · Z-1102-2007: An increased incidence of aggregates was observed in Lot 0036 and 0036A. The presence of aggregates will cause customers to invalidate patient results.

## Indications for use
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.

Source page: https://510kreport.com/device/K050245
Methodology: https://510kreport.com/methodology