Product Classification

• Device: activated partial thromboplastin
• Regulation Description: Partial thromboplastin time tests.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GFO
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.7925
• 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

• 7-159 CLSI H21-A5
  Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
• 7-205 CLSI H47-A2
  One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
• 7-277 CLSI GP41 7th Edition
  Collection of Diagnostic Venous Blood Specimens
• 7-299 CLSI POCT14 2nd Edition
  Point-of-Care Coagulation Testing and Anticoagulation Monitoring

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• sgs north america