# K040898: Cellsearch Epithelial Cell Control Kit

- Pathway: 510(k) (Traditional)
- Applicant: Veridex, LLC
- Decided: Jun 28, 2004 after 83 days
- Product code: NRS (Control Material, Blood Circulating Epithelial Cancer Cell)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Recalls of this device
- Nov 9, 2010 · Not classified · Z-1472-2011: 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 K

## Indications for use
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.

Source page: https://510kreport.com/device/K040898
Methodology: https://510kreport.com/methodology