# K113181: Celltracks Analyer II

- Pathway: 510(k) (Special)
- Applicant: Veridex, LLC
- Decided: Dec 12, 2011 after 45 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: 3 generations back to DEN040001 (2004). 3 ancestors in all.
1 later device descends 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)
- K060110: Celltracks Analyzer II, Immunicon Corp. (2006) Summary page 1.

## Most influential descendants
- 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 CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product 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/K113181
Methodology: https://510kreport.com/methodology