Sterilants/High Level Disinfectants Cleared by FDA in a 510(k) with General Claims for Processing Reusable Medical and Dental Devices

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Device Evaluation Information

FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices
November 2003

Manufacturer	Active Ingredient(s)	Sterilant Contact Conditions	High Level Disinfectant Contact Conditions
K012889 Banicide® Advanced for Sterilization and High Level Disinfection
Pascal Company, Inc.	3.5% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 30 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 25ºC 30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K030004 Cidex® OPA Solution
Advanced Sterilization Products	0.55% ortho-phthaldehyde	No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C and 25°C.	Manual Processing 12 min at 20°C 14 days Maximum Reuse Automated Endoscope Reprocessor (AER) 5 min at 25ºC 14 days Maximum Reuse (For processing in an AER only with FDA-cleared capability to maintain solution temperature at 25ºC.) Contact conditions established by simulated use testing with endoscopes.
K013280 Sterilox Liquid High Level Disinfectant System
Sterilox, Technologies, Inc.	Hypochlorite 650-675 ppm Active free chlorine	No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 24 hrs at 25°C.	10 min at 25ºC Single use - generated on site Contact conditions established by simulated use testing with endoscopes.
K003087 Sporicidin Sterilizing and Disinfecting Solution
Sporicidin International	1.12% glutaraldehyde 1.93% phenol/phenate	Indication for device sterilization. 12 hrs at 25°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	20 min at 25°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K993042 Rapicide™ High Level Disinfectant and Sterilant
MediVators, Inc.	2.5% glutaraldehyde	Indication for device sterilization. 7 hrs 40 min at 35°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes and additional supporting information.	Automated Endoscope Reprocessor 5.0 min at 35°C 28 days Maximum Reuse (For processing in an AER only with FDA-cleared capability to maintain the solution temperature at 35ºC.) Contact conditions established by simulated use testing with endoscopes.
K991487 Cidex®OPA Solution High Level Disinfectant
Advanced Sterilization Products	0.55% ortho-phthaldehyde	No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20°C.	12 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974188 Cetylcide-G^® Concentrate and Diluent Concentrate
Cetylite Industries, Inc.	3.2% glutaraldehyde	Indication for device sterilization. 10 hrs at 20°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	40 min at 20°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K974062 MedSci 3% Glutaraldehyde
MedSci, Inc.	3% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	25 min at 25°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K972708 EndoSpor™ Plus Sterilizing and Disinfecting Solution Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days.
Cottrell Limited	7.35% hydrogen peroxide 0.23% peracetic acid	Indication for device sterilization. 180 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.	15 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K970230 Sporox^TM Sterilizing & Disinfection Solution
Reckitt & Colman Inc.	7.5% hydrogen peroxide	Indication for device sterilization. 6 hrs at 20°C 21 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	30 min at 20°C 21 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K960513 Peract^TM 20 Liquid Sterilant/Disinfectant
Minntech Corporation	1.0% hydrogen peroxide 0.08% peracetic acid	Indication for device sterilization. 8 hrs at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.	25 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K932922 Procide^® 14 N.S.
Cottrell Limited	2.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 20°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 20°C 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K932922 Omnicide^TM Long Life Activated Dialdehyde Solution
Cottrell Limited	2.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 20°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 20°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K932922 Omnicide^TM Plus
Cottrell Limited	3.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 20°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 20°C 28 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K931592 Metricide Plus 30^® Long-Life Activated Dialdehyde Solution
Metrex Research, Inc.	3.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide Plus as identical to Cidex Plus.	90 min at 25°C 28 days Maximum Reuse FDA accepted Metricide Plus as identical to Cidex Plus.
K931052 Metricide^® 28 Long-Life Activated Dialdehyde Solution
Metrex Research, Inc.	2.5% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide 28 as identical to Cidex Formula 7.	90 min at 25°C 28 days Maximum Reuse FDA accepted Metricide 28 as identical to Cidex Formula 7.
K930284 Metricide^® Activated Dialdehyde Solution
Metrex Research, Inc.	2.6% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only. FDA accepted Metricide as identical to Cidex.	45 min at 25°C 14 days Maximum Reuse FDA accepted Metricide as identical to Cidex.
K924434 Cidex™ Activated Dialdehyde Solution
Johnson & Johnson Medical Products	2.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 25°C 14 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 25°C 14 days Maximum Reuse Contact conditions based on literature references.
K924334 Cidex Formula 7™ Long-Life Activated Dialdehyde Solution
Johnson & Johnson Medical Products	2.5% glutaraldehyde	Indication for device sterilization. 10 hrs at 20-25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	90 min at 25°C 28 days Maximum Reuse Contact conditions based on literature references.
K923744 Cidex Plus^TM 28 Day Solution
Johnson & Johnson Medical Products	3.4% glutaraldehyde	Indication for device sterilization. 10 hrs at 20-25°C 28 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	20 min at 25°C 28 days Maximum Reuse Contact conditions based on literature references.
K914749 Wavicide^® - 01
Wave Energy Systems	2.5% glutaraldehyde	Indication for device sterilization. 10 hrs at 22°C 30 days Maximum Reuse Contact conditions based on AOAC Sporicidal Activity Test only.	45 min at 22°C 30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes.
K875280 STERIS 20^TM Sterilant Note: Cleared for use with the STERIS System 1^TM Processor only.
STERIS^®Corporation	0.2% peracetic acid	Indication for device sterilization. 12 min at 50-56°C Single use only. Contact conditions established by simulated use testing with endoscopes and passing a modified AOAC Sporicidal Activity Test.	No indication for high level disinfection.

Updated November 3, 2003

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Center for Devices and Radiological Health / CDRH

FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices November 2003

FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices
November 2003