System, Blood Culturing

Device Code: 3475

Product Code(s): MDB

Device Type ID	3475
Device Name	System, Blood Culturing
Regulation Description	Microbial Growth Monitor.
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	866.2560 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	MDB
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Premarket Reviews
Manufacturer	Decision
BD
	SUBSTANTIALLY EQUIVALENT	5
BECTON DICKINSON
	SUBSTANTIALLY EQUIVALENT	2
BECTON DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	2
BECTON, DICKINSON & CO.
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX
	SUBSTANTIALLY EQUIVALENT	2
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
False Positive Result	274
Incorrect, Inadequate Or Imprecise Result Or Readings	265
Contamination During Use	87
False Negative Result	44
Incorrect Or Inadequate Test Results	20
Overheating Of Device	15
Device Operates Differently Than Expected	15
Device Displays Incorrect Message	15
Device Markings / Labelling Problem	12
Fluid Leak	5
Date/Time-Related Software Problem	4
Break	3
Leak / Splash	3
Crack	2
No Device Output	2
Device Damaged Prior To Use	2
Fracture	2
Device Inoperable	2
Device Contamination With Body Fluid	2
Smoking	2
Use Of Device Problem	1
Deflation Problem	1
Retraction Problem	1
Contamination / Decontamination Problem	1
Adverse Event Without Identified Device Or Use Problem	1
Balloon	1
Loss Of Data	1
Improper Or Incorrect Procedure Or Method	1
Output Problem	1
Pressure Problem	1
Plug	1
Patient Data Problem	1
Intermittent Loss Of Power	1
Total Device Problems	789

TPLC Last Update: 2019-04-02 20:30:48