# K060110: Celltracks Analyzer II

- Pathway: 510(k) (Traditional)
- Applicant: Immunicon Corp.
- Decided: Mar 16, 2006 after 58 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.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050145: Celltracka Analyzer II, Immunicon Corp. (2005) Summary page 1.

## Most influential descendants
- K113181: Celltracks Analyer II (2011), 1 descendant of its own
- K130794: Celltracks Analyzer II System (2013), 0 descendants of its own

## Recalls of this device
- Aug 17, 2011 · Not classified · Z-1004-2012: Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.

## Indications for use
The Immunicon CellTracks Analyzer II is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.

Source page: https://510kreport.com/device/K060110
Methodology: https://510kreport.com/methodology