# NQI: System, Immunomagnetic, Circulating Cancer Cell, Enumeration

- Device class: 2; regulation: 21 CFR 866.6020; FDA's rule: 510(k) required
- FDA decisions: 13
- Recalls: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 1
- 2005: 3
- 2006: 2
- 2007: 1
- 2008: 1
- 2010: 1
- 2011: 1
- 2012: 2
- 2013: 1

## Most-cited predicates
- DEN040001: Cellsearch Epithelial Cell Enrichment Kit; Cellspotter System (2004), cited by 3
- K050145: Celltracka Analyzer II (2005), cited by 1
- K110406: Celltracks Autoprep System (2012), cited by 1
- K071729: Cellsearch Circulating Tumor Cell Kit (2007), cited by 1
- K073338: Cellsearch Circulating Tumor Cell Kit (2008), cited by 1
- K050245: Cellsearch Circulating Tumor Cell Kit (2005), cited by 1
- K060110: Celltracks Analyzer II (2006), cited by 1
- K113181: Celltracks Analyer II (2011), cited by 1
- K062013: Cellsearch Circulating Tumor Cell Kit (2006), cited by 1

Source page: https://510kreport.com/product-code/NQI
Data by year (CSV): https://510kreport.com/product-code/NQI.csv