TPLC - Total Product Life Cycle

• Device: enzymatic method, creatinine
• Product Code: JFY
• Regulation Number: 862.1225
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
HEALTHY.IO LTD
	SUBSTANTIALLY EQUIVALENT	1
HORIBA ABX SAS
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION LABORATORY CO.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
YD DIAGNOSTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	34	34
2019	56	56
2020	34	34
2021	57	57
2022	9	9
2023	30	30

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	72	72
High Test Results	64	64
Non Reproducible Results	33	33
Incorrect, Inadequate or Imprecise Result or Readings	31	31
Adverse Event Without Identified Device or Use Problem	15	15
High Readings	11	11
Insufficient Information	6	6
Appropriate Term/Code Not Available	6	6
Incorrect Measurement	3	3
Low Readings	2	2
Imprecision	1	1
Nonstandard Device	1	1
No Device Output	1	1
Incorrect Or Inadequate Test Results	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	95	95
No Known Impact Or Consequence To Patient	80	80
No Consequences Or Impact To Patient	34	34
Insufficient Information	5	5
No Patient Involvement	3	3
Test Result	3	3
Unspecified Kidney or Urinary Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Beckman Coulter Inc	II	Mar-02-2020
2	Ortho-Clinical Diagnostics	II	Aug-24-2020
3	Ortho-Clinical Diagnostics	III	Sep-19-2018
4	Siemens Healthcare Diagnostics, Inc.	II	Jun-05-2020
5	Siemens Healthcare Diagnostics, Inc.	II	Jan-24-2020