# K073338: Cellsearch Circulating Tumor Cell Kit

- Pathway: 510(k) (Traditional)
- Applicant: Veridex, LLC
- Decided: Feb 26, 2008 after 90 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: 4 generations back to DEN040001 (2004). 4 ancestors in all.
1 later device descends 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)
- K071729: Cellsearch Circulating Tumor Cell Kit, Veridex, LLC (2007) Summary page 2.

## Most influential descendants
- K103502: Cellsearch Circulating Tumor Cell Kit Model 7900001 (2010), 0 descendants of its own

## Recalls of this device
- Aug 12, 2009 · Not classified · Z-0819-2010: 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 detecti

## Indications for use
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

Source page: https://510kreport.com/device/K073338
Methodology: https://510kreport.com/methodology