Product Classification

• Device: indicator, biological sterilization process
• Regulation Description: Sterilization process indicator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FRC
• Submission Type: 510(k)
• Regulation Number: 880.2800
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• USP
• USP
• USP
• USP
• AAMI/ANSI/ISO 11138-1:2006/(R)2010 Sterilization of health care products - Biological indicators - Part 1: General requirements
• USP 35-NF30:2012 Biological Indicator for Steam Sterilization - Self Contained
• USP 35-NF30:2012 Biological Indicator for Dry-Heat Sterilization, Paper Carrier
• USP 35-NF30:2012 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
• USP 35-NF30:2012 Biological Indicator for Steam Sterilization, Paper Carrier

Guidance Document

• FDA Guide for Validation of Biological Indicator Incubation Time

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.