Product Classification

• Device: instrument, coagulation, automated
• Regulation Description: Coagulation instrument.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GKP
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.5400
• 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 Standard

• 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

• aabb
• global quality and regulatory services
• regulatory technology services, llc