Product Classification

• Device: system, multipurpose for in vitro coagulation studies
• Regulation Description: Multipurpose system for in vitro coagulation studies.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: JPA
• Submission Type: 510(k)
• Regulation Number: 864.5425
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
• CLSI H49-A Point-of-Care Monitoring of Anticoagulant Therapy; Approved Guideline
• CLSI H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
• NCCLS H51-A Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor Activity
• CLSI H04-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens

Guidance Document

• 510(k) Submissions for Coagulation Instruments - Guidance for Industry and FDA Staff

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.