# K062013: Cellsearch Circulating Tumor Cell Kit

- Pathway: 510(k) (Traditional)
- Applicant: Veridex, LLC
- Decided: Dec 14, 2006 after 150 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: 2 generations back to DEN040001 (2004). 2 ancestors in all.
3 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)
- K050245: Cellsearch Circulating Tumor Cell Kit, Veridex, LLC (2005) Summary page 1.

## Most influential descendants
- 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 cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearchTM Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring breast cancer. A CTC count of 5 or more per 7.5 mL of blood at any time during the course of the disease is predictive of shorter progression free survival and overall survival.

Source page: https://510kreport.com/device/K062013
Methodology: https://510kreport.com/methodology