Product Classification

• Device: a chemical vapor sterilization multivariable chemical indicator
• Regulation Description: Sterilization process indicator.
• Definition: A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
• Physical State: The device consists of chemicals attached to a non-reactive material surface that react to two or sterilization process parameters.
• Technical Method: Uses chemical reactions to indicate a pass signal to sterilization parameters that are consistent with identified stated values
• Target Area: not intended for patient contact
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: QKM
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Infection Control Devices (DHT4C)
• 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: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 14-601 ISO 17665 First edition 2024-03
  Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

Third Party Review

Not Third Party Eligible