TPLC - Total Product Life Cycle

• Device: test, epithelial ovarian tumor-associated antigen (ca125)
• Product Code: LTK
• Regulation Number: 866.6010
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIOMERIEUX, INC.
	SUBSTANTIALLY EQUIVALENT	2
FUJIREBIO DIAGNOSTICS, INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
ROCHE PROFESSIONAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	30	30
2015	11	11
2016	4	4
2017	15	15
2018	8	8
2019	15	15
2020	5	5
2021	2	2
2022	2	2
2023	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	42	42
Low Test Results	23	23
Adverse Event Without Identified Device or Use Problem	11	11
False Positive Result	10	10
Incorrect Or Inadequate Test Results	5	5
No Apparent Adverse Event	5	5
Non Reproducible Results	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
False Reading From Device Non-Compliance	1	1
Mechanical Problem	1	1
High Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	52	52
No Consequences Or Impact To Patient	30	30
No Clinical Signs, Symptoms or Conditions	10	10
Test Result	2	2
No Code Available	2	2
Misdiagnosis	2	2
Breast Cancer	1	1
Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	BioCheck Inc	II	Mar-11-2011
2	Ortho-Clinical Diagnostics	II	Dec-17-2013
3	Siemens Healthcare Diagnostics, Inc	II	Apr-24-2018
4	Siemens Healthcare Diagnostics, Inc	II	Mar-02-2011
5	Siemens Healthcare Diagnostics, Inc.	II	May-04-2018