TPLC - Total Product Life Cycle

• Device: alkaline picrate, colorimetry, creatinine
• Regulation Description: Creatinine test system.
• Product Code: CGX
• Regulation Number: 862.1225
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT IRELAND DIAGNOSTICS DIVISION
	SUBSTANTIALLY EQUIVALENT	1
NOVA BIOMEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	19	19
2021	13	13
2022	23	23
2023	20	20
2024	35	35
2025	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	71	71
Low Test Results	23	23
Non Reproducible Results	18	18
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Incorrect Measurement	3	3
Labelling, Instructions for Use or Training Problem	2	2
Inaccurate Information	2	2
Output Problem	2	2
Pressure Problem	1	1
Unable to Obtain Readings	1	1
High Readings	1	1
Low Readings	1	1
Improper Flow or Infusion	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	96	96
No Known Impact Or Consequence To Patient	16	16
No Consequences Or Impact To Patient	4	4
Insufficient Information	2	2
Exposure to Body Fluids	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
2	Siemens Healthcare Diagnostics, Inc.	II	Jun-26-2020