Product Classification

• Device: tubes, vials, systems, serum separators, blood collection
• Regulation Description: Blood specimen collection device.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: JKA
• Submission Type: 510(k)
• Regulation Number: 862.1675
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI H04-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens
• CLSI H18-A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
• CLSI LA4-A5 Blood Collection on Filter Paper for Newborn Screening Programs
• CLSI H11-A4 Procedures for the Collection of Arterial Blood Specimens
• CLSI H01-A6 Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
• CLSI GP34-A Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.