Product Classification

• Device: activated partial thromboplastin
• Regulation Description: Partial thromboplastin time tests.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GFO
• Premarket Review: Office of In Vitro Diagnostics and Radiological Health (OIR)
• 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

Recognized Consensus Standards

• 7-112 CLSI POCT14-A (Formerly H49-A)
  Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
• 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

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• biomarkers and diagnostics consulting, llc