Indicator, Physical/chemical Sterilization Process

Device Code: 2614

Product Code(s): JOJ

Device Classification Information

• Device Type ID: 2614
• Device Name: Indicator, Physical/chemical Sterilization Process
• Regulation Description: Sterilization Process Indicator.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Infection Control Devices Branch (INCB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.2800 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JOJ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 14-332 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
• 14-334 ISO 15882 Second Edition 2008-09-01
  Sterilization Of Health Care Products - Chemical Indicators - Guidance For Selection, Use And Interpretation Of Results
• 14-460 ISO 11140-1 Third Edition 2014-11-01
  Sterilization Of Health Care Products - Chemical Indicators - Part 1: General Requirements

Total Product Life Cycle

• Device Type ID: 2614
• Device: Indicator, Physical/chemical Sterilization Process
• Product Code: JOJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Sterilization Process Indicator.
• CFR Regulation Number: 880.2800 [🔎]

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	7
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
CANADIAN TECHNICAL TAPE, LTD.
	SUBSTANTIALLY EQUIVALENT	2
CROSSTEX INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	2
KEM MEDICAL PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
NORTH AMERICAN SCIENCE ASSOC., INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	11
TSO3 INC.
	SUBSTANTIALLY EQUIVALENT	1
U&U MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Chemical Problem	31
Device Operates Differently Than Expected	27
Shelf Life Exceeded	6
Improper Or Incorrect Procedure Or Method	3
Contamination / Decontamination Problem	3
Delivered As Unsterile Product	3
Test Strip	2
Device Expiration Issue	2
Device Handling Problem	2
Insufficient Information	1
Device Rinsing Issue	1
Device Disinfection Or Sterilization Issue	1
Material Discolored	1
Expiration Date Error	1
Appropriate Term/Code Not Available	1
Total Device Problems	85

Recalls
Manufacturer		Recall Class	Date Posted
1	Steris Corporation	II	Mar-10-2014

TPLC Last Update: 2019-04-02 20:16:11