# K071729: Cellsearch Circulating Tumor Cell Kit

- Pathway: 510(k) (Traditional)
- Applicant: Veridex, LLC
- Decided: Nov 20, 2007 after 148 days
- Product code: NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration)
- Device class: 2
- Regulation: 21 CFR 866.6020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN040001 (2004). 3 ancestors in all.
2 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)
- K062013: Cellsearch Circulating Tumor Cell Kit, Veridex, LLC (2006) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The CellSearch TM 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 or metastatic colorectal cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast or metastatic colorectal cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring breast and colorectal 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. The CellSearch system includes: CellSave Preservative Tubes, the CellTracks* AutoPrep® System, the CellTracks® Analyzer II or the CellSpofter® Analyzer, and the CellSearch* Circulating Tumor Cell Control Kit.

Source page: https://510kreport.com/device/K071729
Methodology: https://510kreport.com/methodology