OCC · Class II · 21 CFR 866.3980

FDA Product Code OCC: Respiratory Virus Panel Nucleic Acid Assay System

Under FDA product code OCC, respiratory virus panel nucleic acid assay systems are cleared for multiplex detection of respiratory viral pathogens.

These assays simultaneously identify multiple common respiratory viruses — including influenza A/B, RSV, parainfluenza, adenovirus, and human metapneumovirus — from a single respiratory specimen, enabling rapid and comprehensive viral diagnosis for patient cohorting and treatment decisions.

OCC devices are Class II medical devices, regulated under 21 CFR 866.3980 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Luminex Molecular Diagnostics, Inc., Cepheid and Nanosphere, Inc..

79

Total

78

Cleared

97d

Avg days

2008

Since

79 devices

25–48 of 79

Cleared May 30, 2017

FilmArray Respiratory Panel 2 (RP2)

Biofire Diagnostics, LLC

Microbiology · 90d

Cleared Feb 13, 2017

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Microbiology · 164d

Cleared Feb 09, 2017

Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

Microbiology · 174d

Cleared Dec 21, 2016

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

Alere Scarborough, Inc.

Microbiology · 30d

Cleared Oct 03, 2016

FilmArray Respiratory Panel EZ (RP EZ)

Biofire Diagnostics, LLC

Microbiology · 389d

Cleared Sep 27, 2016

Solana Influenza A+B Assay

Quidel Corporation

Microbiology · 88d

Cleared Aug 18, 2016

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

Alere Scarborough, Inc.

Microbiology · 92d

Cleared Aug 02, 2016

ARIES® Flu A/B & RSV Assay

Luminex Corporation

Microbiology · 95d

Cleared Jul 25, 2016

cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System

Microbiology · 227d

Cleared Feb 08, 2016

FilmArray Respiratory Panel (RP) for use with FilmArray Torch

Biofire Diagnostics, LLC

Microbiology · 26d

Cleared Dec 17, 2015

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

Luminex Molecular Diagnostics, Inc.

Microbiology · 115d

Cleared Dec 03, 2015

Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)

Microbiology · 210d

Cleared Nov 20, 2015

Microbiology · 15d

Cleared Oct 01, 2015

JBAIDS Influenza A & B Detection Kit

U.S Army Medical Materiel Development Activity

Microbiology · 28d

Cleared Sep 21, 2015

Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack

Focus Diagnostics, Inc.

Microbiology · 27d

Cleared Sep 04, 2015

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)

Nanosphere, Inc.

Microbiology · 255d

Cleared Jul 28, 2015

Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

Alere Scarborough, Inc.

Microbiology · 57d

Cleared Feb 17, 2015

FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System

Biofire Diagnostics, LLC

Microbiology · 113d

Cleared Dec 05, 2014

Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack

Focus Diagnostics

Microbiology · 102d

Cleared Nov 22, 2014

XPERT FLU/RSV XC ASSAY

Microbiology · 117d

Cleared Oct 09, 2014

LYRA ADENOVIRUS ASSAY

Quidel Corporation

Microbiology · 85d

Cleared Jun 13, 2014

ALERE I INFLUENZA A & B

Alere Scarborough, Inc D/B/A Binax, Inc.

Microbiology · 4d

Cleared Sep 06, 2013

QUIDEL MOLECULAR RSV + HMPV ASSAY

Microbiology · 78d

Cleared Aug 21, 2013

IMDX FLU A/B AND RSV FOR ABBOTT M2000

Intelligent Medical Devices, Inc.

Microbiology · 82d