Devices descending from K080570
59 later devices reach CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K111778 | Jbaids Influenza a Subtyping Kit | U.S Army Medical Materiel Development Activity | 2011 | 0 | — |
| +1 | K111775 | Jbaids Influenza a&B Detection Kit | U.S. Army Medical Material Development Acitvity | 2011 | 1 | — |
| +1 | K111507 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2011 | 17 | — |
| +1 | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | 5 | — |
| +1 | K100287 | Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136 | U.S. Army Medical Material Development Command | 2010 | 0 | — |
| +1 | K101564 | CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel | Centers for Disease Control and Prevention | 2010 | 19 | — |
| +1 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | 34 | — |
| +1 | K083278 | Avc a/H5N1 Flu Test | Arbor Vita Corportation | 2009 | 0 | — |
| +2 | K152523 | JBAIDS Influenza A & B Detection Kit | U.S Army Medical Materiel Development Activity | 2015 | 0 | — |
| +2 | K132237 | Prodesse Profast+ Assay | Gen-Probe Prodesse, Inc. | 2013 | 0 | — |
| +2 | K130551 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2013 | 15 | — |
| +2 | K123905 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2013 | 0 | — |
| +2 | K121003 | Abbott Plex-ID Flu Assay | Abbott Laboratories | 2012 | 0 | — |
| +2 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software… | Cepheid | 2011 | 27 | 1 |
| +2 | K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) | Nanosphere, Inc. | 2011 | 2 | 1 |
| +3 | K163628 | Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | 2017 | 0 | — |
| +3 | K132508 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2013 | 14 | — |
| +3 | K131584 | Imdx Flu a/B and RSV for Abbott M2000 | Intelligent Medical Devices, Inc. | 2013 | 0 | — |
| +3 | K120911 | Xpert Flu Genexpert DX Systems (GX-I, GX-IV) | Cepheid | 2012 | 7 | — |
| +3 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 18 | 4 |
| +4 | K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems, Inc. | 2019 | 4 | — |
| +4 | K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | Iquum, Inc. | 2016 | 4 | — |
| +4 | K141859 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5 Subtyping | Centers for Disease Control and Prevention | 2014 | 9 | — |
| +4 | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | 11 | 3 |
| +4 | K140851 | Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel | Centers for Disease Control and Prevention | 2014 | 9 | — |
| +4 | K140857 | Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-Time RT-PCR… | Centers for Disease Control and Prevention | 2014 | 8 | — |
| +4 | K133869 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/B Typing Kit | Center For Disease Control and Prevention (Cdc) | 2014 | 8 | — |
| +4 | K123191 | Xpert Flu | Cepheid | 2012 | 6 | — |
| +5 | K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza… | Roche Molecular Systems, Inc. | 2020 | 3 | — |
| +5 | K171641 | Accula Flu A/Flu B Test | Mesa Biotech, Inc. | 2018 | 0 | — |
| +5 | K172091 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit… | Centers for Disease Control and Prevention | 2017 | 7 | — |
| +5 | K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | Centers For Disease Control and Prevention (CDC) | 2016 | 8 | — |
| +5 | K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping | Centers For Disease Control and Prevention (CDC) | 2015 | 8 | — |
| +5 | K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2015 | 8 | — |
| +5 | K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015 | 4 | — |
| +5 | K142045 | Xpert Flu/RSV XC Assay | Cepheid | 2014 | 5 | — |
| +6 | K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas… | Roche Molecular Systems, Inc. | 2026 | 0 | — |
| +6 | K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021 | 1 | — |
| +6 | K190302 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit… | Centers for Disease Control and Prevention | 2019 | 5 | — |
| +6 | K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage… | Centers For Disease Control and Prevention (CDC) | 2018 | 6 | — |
| +6 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018 | 3 | — |
| +6 | K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems… | Cepheid | 2017 | 2 | — |
| +6 | K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems… | Cepheid | 2017 | 0 | — |
| +6 | K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | Alere Scarborough, Inc. | 2016 | 7 | — |
| +6 | K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress… | Cepheid | 2015 | 4 | — |
| +7 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2026 | 0 | — |
| +7 | K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit… | Centers for Disease Control and Prevention | 2025 | 2 | — |
| +7 | K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2022 | 0 | — |
| +7 | K200370 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit… | Centers for Disease Control and Prevention | 2020 | 1 | 1 |
| +7 | K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2019 | 1 | — |
| +7 | K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample… | Cepheid | 2018 | 0 | — |
| +7 | K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample… | Cepheid | 2017 | 1 | — |
| +7 | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2017 | 6 | 1 |
| +8 | K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit… | Centers for Disease Control and Prevention | 2025 | 1 | — |
| +8 | K241110 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit… | Centers for Disease Control and Prevention | 2024 | 0 | — |
| +8 | K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | Abbott Diagnostics Scarborough, Inc. | 2022 | 2 | — |
| +8 | K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2019 | 0 | — |
| +9 | K263035 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B… | Centers for Disease Control and Prevention | 2026 | 0 | — |
| +9 | K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023 | 1 | 2 |