Product Classification

• Device: susceptibility test discs, antimicrobial
• Regulation Description: Antimicrobial susceptibility test disc.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: JTN
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.1620
• 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

• 7-243 CLSI M51-A (Replaces M51-P)
  Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
• 7-262 CLSI M45 3rd Edition
  Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
• 7-278 CLSI M27 4th Edition
  Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
• 7-280 CLSI M02 13th Edition
  Performance Standards for Antimicrobial Disk Susceptibility Tests
• 7-287 CLSI M44-S3 (2018)
  Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
• 7-288 CLSI M24 3rd Edition
  Susceptibility Testing of Mycobacteria, Nocardiae and other Aerobic Actinomycetes
• 7-292 CLSI M62 1st Edition
  Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and other Aerobic Actinomycetes
• 7-304 CLSI M23 5th Edition
  Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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