# DEN040001: Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System

- Pathway: De Novo (Post-NSE)
- Applicant: Advanced Diagnostic Systems
- Decided: Jan 21, 2004 after 19 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
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K050245: Cellsearch Circulating Tumor Cell Kit (2005), 4 descendants of its own
- K062013: Cellsearch Circulating Tumor Cell Kit (2006), 3 descendants of its own
- K050145: Celltracka Analyzer II (2005), 3 descendants of its own
- K071729: Cellsearch Circulating Tumor Cell Kit (2007), 2 descendants of its own
- K060110: Celltracks Analyzer II (2006), 2 descendants of its own

Source page: https://510kreport.com/device/DEN040001
Methodology: https://510kreport.com/methodology