Product Classification

• Device: indicator, physical/chemical sterilization process
• Regulation Description: Sterilization process indicator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: JOJ
• 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

• AAMI/ANSI/ISO 11140-1:2005(R)2010 Sterilization of health care products - Chemical indicators - Part 1: General requirements
• AAMI/ANSI/ISO 15882:2008 Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
• ISO 11140-5 Second edition 2007-03-15 Sterilization of health care products - Chemical indicators ? Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
• ISO 15882 Second edition 2008-09-01 Sterilization of health care products ? Chemical indicators ? Guidance for selection, use and interpretation of results
• ISO 11140-1 Second edition 2005-07-15 Sterilization of health care products - Chemical indicators - Part 1: General requirements
• AAMI/ANSI/ISO 11140-5:2007/(R)2012 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal test sheets and packs

Guidance Document

• Premarket Notification [510(k)] Submissions for Chemical Indicators - Guidance for Industry and FDA Staff

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.