Product Classification

• Device: sterilant, medical devices
• Regulation Description: Liquid chemical sterilants/high level disinfectants.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: MED
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• Submission Type: 510(k)
• Regulation Number: 880.6885
• Device Class: 2
• 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

• 14-212 AOAC 6.2.02:2006
  Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
• 14-213 AOAC 6.2.03:2006
  Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
• 14-215 AOAC 6.2.05:2006
  Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
• 14-217 AOAC 6.3.02:2006
  Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
• 14-397 AOAC 6.2.04:2013
  Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
• 14-398 AOAC 6.3.05:2013
  Official Method 966.04, Sporicidal Activity of Disinfectants Method I
• 14-399 AOAC 6.3.06:2012
  Official Method 965.12 Tuberculocidal Activity of Disinfectants
• 14-412 AOAC 6.2.01:2013
  Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
• 14-413 AOAC 6.2.06:2013
  Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
• 14-432 ANSI AAMI ST58:2013/(R)2018
  Chemical sterilization and high-level disinfection in health care facilities
• 14-551 ISO 14160 Third edition 2020-09
  Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
• 14-597 AAMI ANSI ST108:2023
  Water for the processing of medical devices

Guidance Document

• Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc