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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device respiratory virus panel nucleic acid assay system
Regulation Description Respiratory viral panel multiplex nucleic acid assay.
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
  SUBSTANTIALLY EQUIVALENT 1
Cepheid
  SUBSTANTIALLY EQUIVALENT 3
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LUMINEX MOLECULAR DIAGNOSTICS
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 6
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
False positive result 60
Incorrect or inadequate test results 24
False negative result 2
Incorrect or inadequate result 1
Total Device Problems 87

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 3 3 2
Class III 0 0 0 0 0 0 0 0 0 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 Focus Diagnostics Inc II Apr-02-2016
4 Focus Diagnostics Inc II Jul-01-2014
5 Focus Diagnostics Inc II Jan-28-2014
6 Nanosphere, Inc. II Sep-23-2014
7 Roche Molecular Systems, Inc. II Jul-15-2016
8 Roche Molecular Systems, Inc. III Jul-13-2016
9 Roche Molecular Systems, Inc. II Sep-02-2015

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