Product Classification

• Device: indicator, biological sterilization process
• Regulation Description: Sterilization process indicator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FRC
• Premarket Review: Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B); Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
• Submission Type: 510(k)
• Regulation Number: 880.2800
• 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

• 14-336 ISO 14161 Second edition 2009-09-15
  Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
• 14-566 USP-NF M98795_02_01
  <55> Biological Indicators -- Resistance Performance Tests
• 14-567 USP-NF M7414_01_01
  <1229.5> Biological Indicators for Sterilization
• 14-571 ISO 11138-8 First edition 2021-07
  Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc