# K110406: Celltracks Autoprep System

- Pathway: 510(k) (Special)
- Applicant: Veridex, LLC
- Decided: Jan 20, 2012 after 340 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122821: Celltracks Autoprep System (2012), 0 descendants of its own

## Recalls of this device
- Dec 28, 2012 · Class II · Z-1949-2013: Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of th
- Dec 28, 2012 · Class II · Z-1950-2013: Veridex, LLC has received a report that a patient's demographics were incorrectly associated with another patient's identification (PID) number. The purpose of this notification is to inform you of th

## Indications for use
The CellTracksO AutoPrepO System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer 1l0, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K110406
Methodology: https://510kreport.com/methodology