Product Classification

• Device: counter, differential cell
• Regulation Description: Automated differential cell counter.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GKZ
• Submission Type: 510(k)
• Regulation Number: 864.5220
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI H44-A2 Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline - Second Edition
• CLSI H56-A Body Fluid Analysis for Cellular Composition
• CLSI H43-A2 Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
• CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
• CLSI H42-A2 Enumeration of Immunologically Defined Cell Populations by Flow Cytometry

Guidance Documents

• Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA  
• Draft Guidance for 510(k) Submission of Lymphocyte Immunophenotyping IVDs using Monoclonal Antibodies  

Third Party Review

Not Third Party Eligible