# K100684: Celltracks Autoprep System Model:9541

- Pathway: 510(k) (Traditional)
- Applicant: Veridex, LLC
- Decided: Aug 26, 2010 after 169 days
- Product code: GKH (Apparatus, Automated Blood Cell Diluting)
- Device class: 1
- Regulation: 21 CFR 864.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040077 (2004). 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)
- K040077: Immunicon Celltracks Autoprep System, Immunicon Corp. (2004) Summary page 1.

## Indications for use
The CellTracks® AutoPrep® 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 II®, CellSpotter® System, 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/K100684
Methodology: https://510kreport.com/methodology