Product Classification

• Device: panels, test, susceptibility, antimicrobial
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LTT
• Premarket Review: Division of Microbiology Devices (DMD); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.1640
• 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

• 7-262 CLSI M45 3rd Edition
  Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
• 7-279 CLSI M07 11th Edition
  Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
• 7-304 CLSI M23 5th Edition
  Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
• 7-308 CLSI M100, 31st Edition
  Performance Standards for Antimicrobial Susceptibility Testing
• 7-312 CLSI M39 5th Edition
  Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
• 7-314 CLSI M27M44S, 3rd Edition
  Performance Standards for Antifungal Susceptibility Testing of Yeasts

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• new york state department of health
• regulatory technology services, llc
• sgs north america