TPLC - Total Product Life Cycle

• Device: system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen
• Definition: A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.
• Product Code: NQX
• Regulation Number: 866.1640
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
	SUBSTANTIALLY EQUIVALENT	1
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
	SUBSTANTIALLY EQUIVALENT	1
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	1
CEPHEID
	SUBSTANTIALLY EQUIVALENT	5
ELITECH
	SUBSTANTIALLY EQUIVALENT	1
ELITECHGROUP EPOCH BIOSCIENCES
	SUBSTANTIALLY EQUIVALENT	1
GENEOHM SCIENCES CANADA, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
	SUBSTANTIALLY EQUIVALENT	1
LUMINEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NANOSPHERE, INC
	SUBSTANTIALLY EQUIVALENT	1
ROCHE MOLECULAR SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2015	3	3
2017	1	1
2018	2	2
2021	3	3
2022	5	5
2023	12	12
2024	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	23	23
False Positive Result	4	4
Incorrect Or Inadequate Test Results	2	2
No Apparent Adverse Event	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	25	25
Death	3	3
Staphylococcus Aureus	2	2
Sepsis	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	BD Diagnostics (GeneOhm Sciences, Inc)	II	Sep-10-2009
2	Becton Dickinson & Co.	II	Aug-22-2019
3	Becton Dickinson & Co.	II	Sep-10-2014
4	Becton Dickinson & Co.	II	Sep-06-2012
5	Becton Dickinson & Co.	II	Sep-16-2011
6	Cepheid	II	Aug-16-2016
7	Cepheid	III	Jan-11-2012
8	Cepheid	I	Jul-01-2010
9	Roche Molecular Systems, Inc.	II	Mar-26-2018