Product Classification

• Device: culture media, antimicrobial susceptibility test, excluding mueller hinton agar
• Regulation Description: Culture medium for antimicrobial susceptibility tests.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: JSO
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.1700
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 7-236 CLSI M43-A October 2011
  Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
• 7-262 CLSI M45 3rd Edition
  Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• global quality and regulatory services
• regulatory technology services, llc