Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Device Code: 3347

Product Code(s): JSO

Device Classification Information

• Device Type ID: 3347
• Device Name: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• 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: 866.1700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JSO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-236 CLSI M43-A
  Methods For Antimicrobial Susceptibility Testing For Human Mycoplasmas; Approved Guideline.
• 7-262 CLSI M45 3rd Edition
  Methods For Antimicrobial Dilution And Disk Susceptibility Testing Of Infrequently Isolated Or Fastidious Bacteria.

Total Product Life Cycle

• Device Type ID: 3347
• Device: Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
• Product Code: JSO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• CFR Regulation Number: 866.1700 [🔎]

Premarket Reviews
Manufacturer	Decision
BIOMERIEUX
	SUBSTANTIALLY EQUIVALENT	2
BIOMERIEUX SA
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	2
Bio-Rad Laboratories
	SUBSTANTIALLY EQUIVALENT	1
BIO-RAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HARDY DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
THERMO FISHER SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	38
False Positive Result	33
Incorrect Or Inadequate Test Results	27
False Negative Result	5
Contamination During Use	2
Plate	1
Break	1
Unable To Obtain Readings	1
Total Device Problems	108

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton Dickinson & Co.	II	Mar-09-2018
2	Becton Dickinson & Co.	II	Dec-06-2017
3	Hardy Diagnostics	II	Aug-26-2015
4	Hardy Diagnostics	II	Jul-29-2015
5	Hardy Diagnostics	II	Jul-22-2015

TPLC Last Update: 2019-04-02 20:28:02