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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
Regulation Description B-type natriuretic peptide test system.
Product CodeNBC
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
AXIS-SHIELD DIAGNOSTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K241176  Alere NT-proBNP for Alinity i Reagent Kit
BECKMAN COULTER, 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
2022 4 4
2023 26 27
2024 14 15
2025 17 17
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 44 45
Non Reproducible Results 17 18
High Test Results 15 16
Low Readings 3 4
Incorrect, Inadequate or Imprecise Result or Readings 2 3
High Readings 2 2
Insufficient Information 2 3
False Negative Result 1 1
False Positive Result 1 1
Incorrect Measurement 1 1
Improper or Incorrect Procedure or Method 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 1 1

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