Product Classification

• Device: panels, test, susceptibility, antimicrobial
• Regulation Description: Antimicrobial susceptibility test powder.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LTT
• Submission Type: 510(k)
• Regulation Number: 866.1640
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition
• CLSI M07-A9 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard - Ninth Edition
• CLSI M23-A3 Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline - Third Edition
• CLSI M100-S22 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement

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.