Product Classification

• 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 Code: PMG
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.5220
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc