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TPLC - Total Product Life Cycle
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Device respiratory virus panel nucleic acid assay system
Definition A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
Product CodeOCC
Regulation Number 866.3980
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ALERE SCARBOROUGH, INC D/B/A BINAX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERE SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 5
APPLIED BIOCODE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARGENE SA
  SUBSTANTIALLY EQUIVALENT 1
BIOFIRE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOFIRE DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 4
CEPHEID
  SUBSTANTIALLY EQUIVALENT 8
DIASORIN MOLECULAR LLC
  SUBSTANTIALLY EQUIVALENT 1
FOCUS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
FOCUS DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
GEN-PROBE PRODESSE, INC
  SUBSTANTIALLY EQUIVALENT 3
GEN-PROBE PRODESSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENMARK DIAGNOSTICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
IDAHO TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTELLIGENT MEDICAL DEVICES, INC
  SUBSTANTIALLY EQUIVALENT 1
IQUUM INC
  SUBSTANTIALLY EQUIVALENT 1
IQUUM, INC.
  SUBSTANTIALLY EQUIVALENT 1
JANSSEN PHARMACEUTICA NV
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX MOLECULAR DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MESA BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOSPHERE, INC
  SUBSTANTIALLY EQUIVALENT 5
NANOSPHERE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRODESSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
QIAGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1
QIAGEN, GMBH
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 4
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY
  SUBSTANTIALLY EQUIVALENT 1
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 52 52
2015 1 1
2016 36 36
2017 1 1
2018 1 1
2019 2 2
2020 17 17
2021 686 686
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 753 753
Incorrect, Inadequate or Imprecise Result or Readings 296 296
Output Problem 269 269
Incorrect Or Inadequate Test Results 24 24
Unable to Obtain Readings 10 10
Non Reproducible Results 7 7
False Negative Result 3 3
Labelling, Instructions for Use or Training Problem 1 1
Nonstandard Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Obstruction 1 1
Output below Specifications 1 1
No Apparent Adverse Event 1 1
Under-Sensing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 679 679
Anxiety 642 642
Unspecified Respiratory Problem 629 629
No Consequences Or Impact To Patient 172 172
Insufficient Information 19 19
Respiratory Tract Infection 14 14
Death 4 4
No Known Impact Or Consequence To Patient 3 3
Test Result 2 2
Dyspnea 2 2
Pneumonia 2 2
Misdiagnosis 2 2
Chills 1 1
Sepsis 1 1
Weakness 1 1
Fatigue 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Nausea 1 1
Cough 1 1
Bronchopneumonia 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Viral Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere Scarborough, Inc. dba Binax, Inc. II Jul-16-2015
2 Alere Scarborough, Inc. dba Binax, Inc. II May-26-2015
3 DiaSorin Molecular LLC II Mar-03-2023
4 Focus Diagnostics Inc II Apr-02-2016
5 Focus Diagnostics Inc II Jul-01-2014
6 Focus Diagnostics Inc II Jan-28-2014
7 Hologic, Inc II May-28-2020
8 Luminex Corporation II Jul-02-2021
9 Luminex Corporation II Oct-05-2020
10 Luminex Molecular Diagnostics II Oct-18-2019
11 Nanosphere, Inc. II Sep-23-2014
12 Quidel Corporation II Feb-22-2017
13 Roche Molecular Systems, Inc. II Jul-15-2016
14 Roche Molecular Systems, Inc. III Jul-13-2016
15 Roche Molecular Systems, Inc. II Sep-02-2015
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