Product Classification

• Device: positive blood culture identification and ast kit
• Definition: Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.
• Physical State: In vitro diagnostic device
• Technical Method: Direct Fluorescence in situ hybridization (FISH) identification and antimicrobial susceptibility testing (AST) of microbes growing in positive blood cultures
• Target Area: Direct identification and antimicrobial susceptibility testing of microbes in positive blood cultures
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: PRH
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.1650
• 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 Standard

• 7-312 CLSI M39 5th Edition
  Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data

Third Party Review

Not Third Party Eligible