TPLC - Total Product Life Cycle

• Device: antibodies, anti-cyclic citrullinated peptide (ccp)
• Definition: The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
• Product Code: NHX
• Regulation Number: 866.5775
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AXIS-SHIELD DIAGNOSTICS LIMITED.
	SUBSTANTIALLY EQUIVALENT	1
AXIS-SHIELD DIAGNOSTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
BIO-RAD LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
EURO-DIAGNOSTICA AB
	SUBSTANTIALLY EQUIVALENT	2
INOVA DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
THERATEST LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2015	4	4
2016	4	4
2017	1	1
2018	4	4
2019	13	13
2020	3	3
2023	6	6
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	20	20
Non Reproducible Results	13	13
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Incorrect Or Inadequate Test Results	1	1
Low Test Results	1	1
Device Markings/Labelling Problem	1	1
False Positive Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	22	22
No Known Impact Or Consequence To Patient	7	7
No Clinical Signs, Symptoms or Conditions	7	7
No Patient Involvement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bio-Rad Laboratories, Inc.	II	Apr-12-2023
2	Euro Diagnostica AB	II	Aug-23-2018
3	Phadia US Inc	II	Feb-24-2017
4	Roche Diagnostics Operations, Inc.	II	Aug-23-2019
5	Siemens Healthcare Diagnostics, Inc	II	Sep-26-2019