TPLC - Total Product Life Cycle

• Device: system, test, c-reactive protein
• Product Code: DCN
• Regulation Number: 866.5270
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABAXIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HITACHI CHEMICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MESO SCALE DIAGNOSTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MITSUBISHI KAGAKU IATRON
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTIC PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
THE BINDING SITE GROUP
	SUBSTANTIALLY EQUIVALENT	1
THE BINDING SITE GROUP LTD
	SUBSTANTIALLY EQUIVALENT	1
THE BINDING SITE GROUP LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	2	2
2015	2	2
2016	1	1
2018	2	2
2019	8	8
2021	1	1
2022	1	1
2023	4	4
2024	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	12	12
High Test Results	9	9
Non Reproducible Results	6	6
Incorrect Measurement	1	1
Incorrect Or Inadequate Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	11	11
No Clinical Signs, Symptoms or Conditions	10	10
No Known Impact Or Consequence To Patient	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Roche Diagnostics Operations, Inc.	II	Dec-17-2020
2	Siemens Healthcare Diagnostics, Inc.	III	Sep-08-2009
3	The Binding Site Group, Ltd.	II	Mar-31-2020
4	The Binding Site Group, Ltd.	II	Dec-12-2019