Influenza Diagnostic Tests
July 22, 2024
Laboratory developed tests (LDTs) for Highly Pathogenic Avian Influenza (HPAI) offered by clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing currently fall under the FDA’s general enforcement discretion approach for LDTs. The FDA generally does not expect clinical laboratories that are certified under CLIA and qualified to perform high-complexity testing to request marketing authorization from the FDA for their LDTs for HPAI prior to them offering those LDTs. And the FDA would not issue EUAs for such IVDs given that there is no relevant section 564 declaration.
Highly Pathogenic Avian Influenza (HPAI) is a disease that is highly contagious and often deadly in poultry, caused by highly pathogenic avian influenza A (H5) and A (H7) viruses; it is also known as bird or avian flu. HPAI viruses can be transmitted by wild birds to domestic poultry and other bird and animal species. Although bird flu viruses do not normally infect humans, sporadic human infections have occurred. It is important to note that “highly pathogenic” refers to severe impact in birds, not necessarily in humans.
According to the U.S. Centers for Disease Control and Prevention (CDC), avian (bird) influenza (flu) A rarely infects people. CDC continues to monitor emergency department data and flu testing data for any unusual trends in flu-like illness, flu, or conjunctivitis. To date, surveillance systems do not show any unusual trends or activity.
In vitro diagnostic (IVD) products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions. IVDs include tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person's overall health to help diagnose, cure, treat, or prevent diseases.
In response to requests from the public, the FDA is providing a list of in vitro diagnostic tests that have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA), for the detection of influenza in certain specimens from humans. Most tests listed below for the detection of seasonal influenza may be capable of detecting influenza A/H5N1, which is a subtype of influenza A. However, only tests specifically designed for subtyping will be able to determine if the person has seasonal flu, or influenza A/H5.
Influenza A/H5 Subtyping Tests
| Manufacturer | Device Name | Virus Detection Method | Authorization |
|---|---|---|---|
|
Centers For Disease Control and Prevention |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit, Influenza A Subtyping Kit (VER 2), Influenza B Lineage Genotyping Kit (VER 1.1 and VER 2), and Influenza A/H5 Subtyping Kit (VER 3) |
Nucleic Acid Detection |
Influenza A/H5N1 Specific Detection Test
| Manufacturer | Device Name | Virus Detection Method | Authorization |
|---|---|---|---|
|
Arbor Vita Corporation |
AVantage A/H5N1 Flu Test |
Antigen Detection |
Influenza A/H1/H1pdm09/H3 Seasonal Subtyping Tests
| Manufacturer | Device Name | Virus Detection Method | Authorization |
|---|---|---|---|
| Centers For Disease Control and Prevention | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit, Influenza A Subtyping Kit (VER 2), Influenza B Lineage Genotyping Kit (VER 1.1 and VER 2), and Influenza A/H5 Subtyping Kit (VER 3) | Nucleic Acid Detection | K190302 |
| Applied BioCode, Inc. | BioCode CoV-2 Flu Plus Assay | Nucleic Acid Detection | EUA203142 |
| BioFire Diagnostics, LLC | BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) | Nucleic Acid Detection | EUA202392 |
| GenMark Diagnostics, Inc. | ePlex Respiratory Pathogen Panel 2 | Nucleic Acid Detection | EUA201822 |
| Luminex Molecular Diagnostics, Inc. | NxTAG Respiratory Pathogen Panel + SARS-CoV-2 | Nucleic Acid Detection | EUA210031 |
| QIAGEN GmbH | QIAstat-Dx Respiratory SARS-CoV-2 Panel | Nucleic Acid Detection | EUA200075 |
| Applied BioCode, Inc. | BioCode Respiratory Pathogen Panel (RPP) | Nucleic Acid Detection | K192485 |
| Biocartis NV | Idylla Respiratory (IFV-RSV) Panel | Nucleic Acid Detection | K163628 |
| Biofire Diagnostics, LLC | BioFire Respiratory Panel 2.1 (RP2.1) | Nucleic Acid Detection | DEN200031 |
| BioFire Diagnostics, LLC | FilmArray Pneumonia Panel | Nucleic Acid Detection | K212727 |
| BioFire Diagnostics, LLC | FilmArray Pneumonia Panel plus | Nucleic Acid Detection | K222601 |
| BioFire Diagnostics, LLC | FilmArray Respiratory Panel (RP) For use with FilmArray Torch | Nucleic Acid Detection | K160068 |
| BioFire Diagnostics, LLC | BIOFIRE SPOTFIRE Respiratory (R) Panel | Nucleic Acid Detection | K213954 |
| BioFire Diagnostics, LLC | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Nucleic Acid Detection | K232954 |
| GenMark Diagnostics, Inc. | eSensor Respiratory Viral Panel (RVP) | Nucleic Acid Detection | K113731 |
| GenMark Diagnostics, Inc. | ePlex Respiratory Pathogen (RP) Panel | Nucleic Acid Detection | K163636 |
| Luminex Corporation | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Nucleic Acid Detection | K143653 |
| Luminex Molecular Diagnostics, Inc. | NxTAG Respiratory Pathogen Panel | Nucleic Acid Detection | K152386 |
| Luminex Molecular Diagnostics, Inc. | xTAG RVP (Respiratory Viral Panel) | Nucleic Acid Detection | DEN070013 |
| Qiagen GmbH | QIAstat-Dx Respiratory Panel Plus | Nucleic Acid Detection | K233100 |
Influenza A Tests (no subtyping)
| Manufacturer | Device Name | Virus Detection Method | Authorization |
|---|---|---|---|
| Abbott Molecular Inc. | Alinity m Resp-4-Plex | Nucleic Acid Detection | EUA202930 |
| Centers for Disease Control and Prevention (CDC) | Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay | Nucleic Acid Detection | EUA201781 |
| Cepheid | Xpert Xpress CoV-2/Flu/RSV plus | Nucleic Acid Detection | EUA210505 |
| Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute | SelfCheck cobas SARS-CoV-2 + Flu Assay | Nucleic Acid Detection | EUA220184 |
| Everlywell, Inc. | Everlywell COVID-19 & Flu Test Home Collection Kit** | Nucleic Acid Detection | EUA203029 |
| Hologic, Inc. | Aptima SARS-CoV-2/Flu assay | Nucleic Acid Detection | EUA202959 |
| Laboratory Corporation of America (Labcorp) | Labcorp SARS-CoV-2 & Influenza A/B Assay | Nucleic Acid Detection | EUA210522 |
| Laboratory Corporation of America (Labcorp) | Labcorp Seasonal Respiratory Virus RT-PCR Test | Nucleic Acid Detection | EUA210592 |
| Laboratory Corporation of America (Labcorp) | Labcorp Seasonal Respiratory Virus RT-PCR DTC Test | Nucleic Acid Detection | EUA220163 |
| LumiraDx UK Ltd. | LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay | Nucleic Acid Detection | EUA220457 |
| OPTI Medical Systems, Inc | OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2) | Nucleic Acid Detection | EUA210615 |
| Pfizer Inc. | Lucira by Pfizer COVID-19 & Flu Test | Nucleic Acid Detection | EUA220333 |
| Pfizer Inc. | Lucira by Pfizer COVID-19 & Flu Home Test* | Nucleic Acid Detection | EUA220490 |
| Quest Diagnostics Nichols Institute | Quest Diagnostics RC COVID-19+Flu RT-PCR | Nucleic Acid Detection | EUA202887 |
| Revvity, Inc. | Respiratory SARS-CoV-2 RT-PCR Panel 1 | Nucleic Acid Detection | EUA202791 |
| Roche Molecular System | cobas SARS-CoV-2 & Influenza A/B v2 | Nucleic Acid Detection | EUA230046 |
| Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B | Nucleic Acid Detection | EUA202635 |
| Thermo Fisher Scientific | TaqPath COVID-19, FluA, FluB Combo Kit | Nucleic Acid Detection | EUA202953 |
| Visby Medical, Inc. | Visby Medical Respiratory Health Test | Nucleic Acid Detection | EUA220437 |
| Quidel Corporation | Sofia 2 Flu + SARS Antigen FIA | Antigen Detection | EUA202751 |
| Becton, Dickinson and Company (BD) | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B | Antigen Detection | EUA203152 |
| Princeton BioMeditech Corp. | Status COVID-19/Flu A&B | Antigen Detection | EUA210015 |
| Princeton BioMeditech Corp. | ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test | Antigen Detection | EUA220131 |
| Princeton BioMeditech Corp. | Status COVID-19 Antigen Rapid Test for Home Use* | Antigen Detection | EUA220119 |
| OSANG LLC | OHC COVID-19/Flu Antigen Test Pro | Antigen Detection | EUA230042 |
| SEKISUI Diagnostics, LLC | OSOM Flu SARS-CoV-2 Combo Test | Antigen Detection | EUA230045 |
| CorDx, Inc. | CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test | Antigen Detection | EUA230055 |
| iHealth Labs, Inc. | iHealth COVID-19/Flu A&B Rapid Test* | Antigen Detection | EUA230053 |
| SEKISUI Diagnostics, LLC | OSOM Flu SARS-CoV-2 Combo Home Test* | Antigen Detection | EUA240002 |
| Wondfo USA Co., Ltd. | WELLlife COVID-19 / Influenza A&B Home Test* | Antigen Detection | EUA240004 |
| CorDx, Inc. | CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test* | Antigen Detection | EUA240006 |
| OSANG LLC | QuickFinder COVID-19/Flu Antigen Self Test* | Antigen Detection | EUA240007 |
| Abbott Diagnostics Scarborough, Inc. | Alere i Influenza A&B, Alere i Instrument, ID NOW Instrument | Nucleic Acid Detection | K141520 |
| Abbott Diagnostics Scarborough, Inc. | Alere i Influenza A & B 2 Test, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Nucleic Acid Detection | K171792 |
| Abbott Molecular, Inc. | IMDx Flu A/B and RSV for Abbott m2000 | Nucleic Acid Detection | K131584 |
| BioFire Diagnostics, LLC | BIOFIRE SPOTFIRE Respiratory (R) Panel Mini | Nucleic Acid Detection | K230719 |
| Cepheid | Xpert Xpress Flu Assay | Nucleic Acid Detection | K171552 |
| Cepheid | Xpert Flu/RSV XC Assay | Nucleic Acid Detection | K142045 |
| Cepheid | Xpert Xpress Flu/RSV | Nucleic Acid Detection | K162331 |
| Cepheid | Xpert Xpress Flu/RSV Assay | Nucleic Acid Detection | K180218 |
| Cepheid | Xpert Xpress CoV-2/Flu/RSV plus | Nucleic Acid Detection | K231481 |
| DiaSorin Molecular LLC | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Nucleic Acid Detection | K201505 |
| DiaSorin Molecular LLC | Simplexa COVID-19 & Flu A/B Direct | Nucleic Acid Detection | K220963 |
| Hologic, Inc. | Panther Fusion Flu A/B/RSV Assay | Nucleic Acid Detection | K171963 |
| Hologic, Inc. | Panther Fusion SARS CoV-2/Flu A/B/RSV Assay | Nucleic Acid Detection | K222736 |
| Luminex Corporation | ARIES Flu A/B & RSV Assay | Nucleic Acid Detection | K161220 |
| Mesa Biotech, Inc. | Accula Flu A/Flu B Test | Nucleic Acid Detection | K171641 |
| QIAGEN GmbH | QIAstat-Dx Respiratory Panel | Nucleic Acid Detection | K183597 |
| Quidel Corporation | Solana Influenza A+B Assay | Nucleic Acid Detection | K161814 |
| Roche Molecular Systems, Inc. | Liat Influenza A/B Assay, Liat Analyzer | Nucleic Acid Detection | K111387 |
| Roche Molecular Systems, Inc. | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | Nucleic Acid Detection | K153544 |
| Roche Molecular Systems, Inc. | cobas SARS-CoV-2 & Influenza A/B for use on the cobas Liat System | Nucleic Acid Detection | K223591 |
| Abbott Diagnostics Scarborough, Inc. | BinaxNOW Influenza A & B | Antigen Detection | K092223 |
| Abbott Diagnostics Scarborough, Inc. | Alere BinaxNOW Influenza A & B Card 2 | Antigen Detection | K162642 |
| Becton, Dickinson and Company | BD Veritor System for Rapid Detection of Flu A+B | Antigen Detection | K151291 |
| Becton, Dickinson and Company | BD Veritor System for Rapid Detection of Flu A+B Laboratory kit | Antigen Detection | K160164 |
| Becton, Dickinson and Company | BD Veritor System Flu A+B Assay | Antigen Detection | K151301 |
| Becton, Dickinson and Company | BD Veritor System for Rapid Detection of Flu A+B CLIA waived kit | Antigen Detection | K180438 |
| Hamamatsu Photonics Electron Tube Division | Acucy Influenza A&B Test with the Acucy System | Antigen Detection | K182001 |
| Diagnostic Products Corp. | PathoDX Respiratory Virus Panel, Model PKRP1 | Antigen Detection | K983336 |
| Princeton BioMeditech Corporation | BioSign Flu A+B | Antigen Detection | K133474 |
| Quidel Corp. | QuickVue Influenza A+B Test | Antigen Detection | K991633 |
| Quidel Corp. | Sofia Analyzer, Sofia Influenza A+B FIA | Antigen Detection | K112177 |
| SA Scientific, Ltd. | SAS FluAlert A&B Test | Antigen Detection | K080380 |
| Sekisui Diagnostics, LLC | Osom Ultra Plus Flu A&B Test Kit | Antigen Detection | K192719 |
| Thermo Fisher Scientific | Xpect Flu A&B | Antigen Detection | K092423 |
| Healgen Scientific, LLC | Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) | Antigen Detection | EUA240010 |
| iHealth Labs, Inc. | iHealth COVID-19/Flu A&B Rapid Test Pro | Antigen Detection | EUA240005 |
| Watmind USA | Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test | Antigen Detection | EUA240014 |
| Wondfo USA Co., Ltd. | WELLlife COVID-19 / Influenza A&B Test | Antigen Detection | EUA240004 |
| Watmind USA | Speedy Swab Rapid COVID-19 + Flu A&B Antigen Test | Antigen Detection | EUA230037 |
| BioFire Diagnostics, LLC | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | Nucleic Acid Detection | K241194 |
Note:
Tests marked with (*) have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA) for home use.
Tests marked with (**) have FDA 510(k) clearance, or granted de novo request, or are authorized for emergency use (EUA) for use with home collected specimens.
Please be aware that one FDA 510(k) clearance, granted de novo request, or emergency use authorization (EUA) is linked for each device name. There may be additional FDA 510(k) clearances, granted de novo requests, or EUAs due to changes made over time while retaining the same device name.