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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device devices detecting influenza a, b, and c virus antigens
Regulation Description Influenza virus antigen detection test system.
Definition An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Product CodePSZ
Regulation Number 866.3328
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 2
INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANO-DITECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SEKISUI DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 42 42
2022 10 10
2023 12 12
2024 16 16
2025 60 60
2026 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 85 85
Incorrect, Inadequate or Imprecise Result or Readings 54 54
False Negative Result 13 13
Device Markings/Labelling Problem 2 2
Inaccurate Information 2 2
Device Ingredient or Reagent Problem 1 1
Break 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 156 156
No Consequences Or Impact To Patient 9 9
Insufficient Information 2 2
Malaise 1 1
Taste Disorder 1 1
Test Result 1 1
Pain 1 1
Chills 1 1
Pneumonia 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Feb-09-2022
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