Product Classification

• Device: susceptibility test plate, antifungal
• Regulation Description: Antimicrobial susceptibility test powder.
• Definition: The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: NGZ
• 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

• 7-243 CLSI M51-A (Replaces M51-P)
  Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
• 7-278 CLSI M27 4th Edition
  Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
• 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
• 7-304 CLSI M23 5th Edition
  Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters
• 7-314 CLSI M27M44S, 3rd Edition
  Performance Standards for Antifungal Susceptibility Testing of Yeasts
• 7-319 CLSI M23 6th Edition
  Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters

Third Party Review

Not Third Party Eligible