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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, natriuretic peptide
Product CodeNBC
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
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
2019 9 9
2020 6 6
2022 4 4
2023 26 26
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 42 42
Non Reproducible Results 15 15
High Test Results 14 14
Incorrect, Inadequate or Imprecise Result or Readings 3 3
False Negative Result 2 2
Insufficient Information 2 2
High Readings 2 2
Low Readings 2 2
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 47 47
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Edema 1 1
Congestive Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Oct-26-2020
2 ORTHO-CLINICAL DIAGNOSTICS II Jan-03-2019
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