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U.S. Department of Health and Human Services

Product Classification

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Device automated multicolor fluorescent imaging cytometric analysis system
Regulation Description Automated differential cell counter.
Definition An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.G., hemoglobin) using spectrophotometric absorbance measurement and fluorescence measurements.
Physical State System may include image cytometer, assay-specific single-use reagent cartridges and reagents, specimen and process controls, dedicated instrument control, data acquisition software and other essential hardware components.
Technical Method System identifies and enumerates specific leukocyte populations using immunophenotyping methods and image cytometry. System performs quantification and enumeration of cells using specific fluorescently labeled conjugated antibodies to bind to leukocytes expressing corresponding immunologic markers. The system also uses spectrophotometric methods for measurement of hemoglobin concentration in whole blood specimens.
Target Area Human whole blood
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePMG
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible