# K050145: Celltracka Analyzer II

- Pathway: 510(k) (Traditional)
- Applicant: Immunicon Corp.
- Decided: Mar 15, 2005 after 50 days
- Product code: NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration)
- Device class: 2
- Regulation: 21 CFR 866.6020
- Recalls of this device: 2 (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.
3 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)
- 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.
- (no number) Veridex LLC CellSearch Epithelial Cell kit/Cell Spotter Analyzer: named in the summary without a submission number

## Most influential descendants
- K060110: Celltracks Analyzer II (2006), 2 descendants of its own
- 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
- Jan 8, 2014 · Class II · Z-1195-2014: Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿.
- 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/K050145
Methodology: https://510kreport.com/methodology