# K130794: Celltracks Analyzer II System

- Pathway: 510(k) (Traditional)
- Applicant: Veridex, LLC
- Decided: Jun 20, 2013 after 90 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: 4 generations back to DEN040001 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113181: Celltracks Analyer II, Veridex, LLC (2011) Summary page 2.

## 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¿.

## 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/K130794
Methodology: https://510kreport.com/methodology