Product Classification

• Device: hexokinase, glucose
• Regulation Description: Glucose test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: CFR
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1345
• 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

• 7-284 CLSI EP37 1st Edition
  Supplemental Tables for Interference Testing in Clinical Chemistry
• 7-301 CLSI GP42 7th Edition
  Collection of Capillary Blood Specimens
• 13-88 IEEE ISO 11073-10417 Third edition 2017-04
  Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
• 13-90 IEEE Std 11073-10417-2015
  Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• center for measurement standards of industrial
• cola, inc.
• global quality and regulatory services
• regulatory technology services, llc