Product Classification

• Device: system, test, automated, antimicrobial susceptibility, short incubation
• Regulation Description: Fully automated short-term incubation cycle antimicrobial susceptibility system.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LON
• Premarket Review: Division of Microbiology Devices (DMD); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.1645
• 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
• 7-312 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
• 7-317 CLSI M100, 33rd Edition
  Performance Standards for Antimicrobial Susceptibility Testing
• 7-319 CLSI M23 6th Edition
  Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters

Guidance Documents

• Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDa

• Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible