TPLC - Total Product Life Cycle

• Device: prostate-specific antigen (psa) for management of prostate cancers
• Product Code: LTJ
• Regulation Number: 866.6010
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
NANOEN TEK, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANOENTEK USA INC
	SUBSTANTIALLY EQUIVALENT	1

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	0	0	0	2	9	7	2	1	2	0	2	1

MDR Year	MDR Reports	MDR Events
2014	19	19
2015	14	14
2016	8	8
2017	13	13
2018	8	8
2019	11	11
2020	4	4
2021	8	8
2022	11	11
2023	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	43	43
High Test Results	36	36
Incorrect Measurement	20	20
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Incorrect Or Inadequate Test Results	6	6
Non Reproducible Results	4	4
Defective Device	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Failure to Calibrate	1	1
Nonstandard Device	1	1
False Positive Result	1	1
False Reading From Device Non-Compliance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	51	51
No Clinical Signs, Symptoms or Conditions	32	32
No Consequences Or Impact To Patient	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Code Available	2	2
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc	II	Apr-28-2009
2	BioCheck Inc	II	Mar-11-2011
3	Qualigen Inc	II	Dec-19-2013
4	Siemens Healthcare Diagnostics, Inc	II	Sep-07-2016
5	Tosoh Bioscience Inc	II	Jun-05-2018