Product Classification

• Device: system, blood culturing
• Regulation Description: Microbial growth monitor.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: MDB
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.2560
• Device Class: 1
• 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

• 7-189 CLSI M47-A (Replaces M47-P)
  Principles and Procedures for Blood Cultures; Approved Guideline
• 7-322 CLSI M47 2nd Edition
  Principles and Procedures for Blood Cultures

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