# K040077: Immunicon Celltracks Autoprep System

- Pathway: 510(k) (Traditional)
- Applicant: Immunicon Corp.
- Decided: Mar 12, 2004 after 58 days
- Product code: GKH (Apparatus, Automated Blood Cell Diluting)
- Device class: 1
- Regulation: 21 CFR 864.5240
- 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. The FDA summary names its predicate without a number.
- (no number) Immunicon CellPrep Sample Preparation system: named in the summary without a submission number

## Most influential descendants
- K100684: Celltracks Autoprep System Model:9541 (2010), 0 descendants of its own

## Recalls of this device
- May 19, 2010 · Not classified · Z-2175-2010: Complaints of patient sample carryover.
- May 6, 2009 · Not classified · Z-1734-2009: Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.

## Indications for use
The intended use for the Immunicon CellTracks™ AutoPrep System is as 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, 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/K040077
Methodology: https://510kreport.com/methodology