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
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1675
• 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

• 7-213 CLSI GP44-A4 (Formerly H18-A4)
  Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
• 7-221 CLSI GP39-A6 (Formerly H01-A6)
  Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
• 7-225 CLSI GP34-A (Replaces GP34-P)
  Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
• 7-244 CLSI NBS01-A6 (Replaces LA04-A5)
  Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
• 7-277 CLSI GP41 7th Edition
  Collection of Diagnostic Venous Blood Specimens
• 7-301 CLSI GP42 7th Edition
  Collection of Capillary Blood Specimens
• 7-316 CLSI NBS01 7th Edition
  Dried Blood Spot Specimen Collection for Newborn Screening

Third Party Review

Not Third Party Eligible