FDAnews Device Daily Bulletin

CellTracks Analyzer II Receives 510(k) for IVD Use

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Immunicon announced that the CellTracks Analyzer II was cleared by the FDA for in vitro diagnostic (IVD) use through the 510(k) premarket notification process.

The Immunicon CellTracks Analyzer II is a semiautomated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system 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.

CellTracks Analyzer II is used in conjunction with kits that incorporate Immunicon reagent technologies and the CellTracks AutoPrep System, which automates, standardizes and optimizes sample preparation. Immunicon anticipates release for sale in the second quarter of 2005.