Product Classification

• Device: counter, differential cell
• Regulation Description: Automated differential cell counter.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GKZ
• 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

Recognized Consensus Standards

• 7-145 CLSI H42-A2 (Replaces H42-A)
  Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
• 7-150 CLSI H43-A2
  Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
• 7-163 CLSI H56-A (Replaces H56-P)
  Body Fluid Analysis for Cellular Composition; Approved Guideline.
• 7-165 CLSI H20-A2 (Replaces H20-A)
  Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
• 7-210 CLSI H26-A2
  Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
• 7-277 CLSI GP41 7th Edition
  Collection of Diagnostic Venous Blood Specimens

Guidance Documents

• Guidance for Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells

• 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

Third Party Review

Not Third Party Eligible