Panels, Test, Susceptibility, Antimicrobial

Device Code: 3462

Product Code(s): LTT

Device Classification Information

• Device Type ID: 3462
• Device Name: Panels, Test, Susceptibility, Antimicrobial
• Regulation Description: Antimicrobial Susceptibility Test Powder.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.1640 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LTT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 7-254 CLSI M07-A10
  Methods For Dilution Antimicrobial Susceptibility Tests For Bacteria That Grow Aerobically; Approved Standard - Tenth Edition
• 7-261 CLSI M23 Fourth Edition (Replaces M23-A3)
  Development Of In Vitro Susceptibility Testing Criteria And Quality Control Parameters.
• 7-262 CLSI M45 3rd Edition
  Methods For Antimicrobial Dilution And Disk Susceptibility Testing Of Infrequently Isolated Or Fastidious Bacteria.
• 7-271 CLSI M100 27th Edition (Replaces M100-S26)
  Performance Standards For Antimicrobial Susceptibility Testing
• 7-279 CLSI M07 11th Edition
  Methods For Dilution Antimicrobial Susceptibility Tests For Bacteria That Grow Aerobically
• 7-281 CLSI M100 28th Edition
  Performance Standards For Antimicrobial Susceptibility Testing

Total Product Life Cycle

• Device Type ID: 3462
• Device: Panels, Test, Susceptibility, Antimicrobial
• Product Code: LTT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Antimicrobial Susceptibility Test Powder.
• CFR Regulation Number: 866.1640 [🔎]

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER
	SUBSTANTIALLY EQUIVALENT	5
BECKMAN COULTER INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	4
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	4
Appropriate Term/Code Not Available	1
False Negative Result	1
Total Device Problems	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc.	II	Aug-02-2018
2	Beckman Coulter Inc.	II	Dec-30-2015
3	Beckman Coulter Inc.	II	Oct-07-2015

TPLC Last Update: 2019-04-02 20:30:35