Product Classification

• Device: transport systems, anaerobic
• Regulation Description: Microbiological specimen collection and transport device.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: JTX
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.2900
• Device Class: 1
• 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

• 7-250 CLSI M40-A2 (Reaffirmed: September 2019)
  Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
• 7-300 CLSI MM13 2nd Edition
  Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods

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