TPLC - Total Product Life Cycle

• Device: test, natriuretic peptide
• Regulation Description: B-type natriuretic peptide test system.
• Product Code: NBC
• Regulation Number: 862.1117
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AXIS-SHIELD DIAGNOSTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIREBIO DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO CLINICAL DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	2
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOSOH BIOSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	6	6
2022	4	4
2023	26	26
2024	18	18
2025	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Low Test Results	48	48
Non Reproducible Results	18	18
High Test Results	15	15
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Low Readings	3	3
Insufficient Information	2	2
High Readings	2	2
False Negative Result	1	1
Output Problem	1	1
No Apparent Adverse Event	1	1
Failure to Calibrate	1	1
False Positive Result	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	58	58
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Known Impact Or Consequence To Patient	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medline Industries Inc	II	Oct-26-2020