Product Classification

• Device: fibrinogen and fibrin split products, antigen, antiserum, control
• Regulation Description: Fibrinogen/fibrin degradation products assay.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: DAP
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.7320
• 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
• 7-220 CLSI H59-A (Replaces H59-P)
  Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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