Product Classification

• Device: glucose dehydrogenase, glucose
• Regulation Description: Glucose test system.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: LFR
• Submission Type: 510(k)
• Regulation Number: 862.1345
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI C30-A2 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities
• ISO 15197 First edition 2003-05-01 In Vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
• CLSI H04-A6 Procedures and Devices for the Collection of Diagnostic Capillary Blood Specimens

Guidance Documents

• Guidance for Industry In Vitro Diagnostic Glucose Test System; Final  
• Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology  
• Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.