# K122821: Celltracks Autoprep System

- Pathway: 510(k) (Special)
- Applicant: Veridex, LLC
- Decided: Dec 13, 2012 after 90 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 K110406 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110406: Celltracks Autoprep System, Veridex, LLC (2012) Summary page 2.

## 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 CELLTRACKS® AUTOPREP® System is a laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS ANALYZER 11® may be used for cell identification and enumeration. The system is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K122821
Methodology: https://510kreport.com/methodology