510(k) Report

Devices descending from K073029

85 later devices reach Proflu+ Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.20164—
+1K121003Abbott Plex-ID Flu AssayAbbott Laboratories20120—
+1K120413Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control PackFocus Diagnostics, Inc.201232
+1K110968Proflu+ AssayGen-Probe Prodesse, Inc.201115—
+1K103766Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…Cepheid2011271
+1K102170Simplexa Flu a/B & RSVFocus Diagnostics, Inc.20100—
+1K101855Profast+ AssayGen-Probe Prodesse, Inc.20105—
+1K083088Verigene Respiratory Virus Nucleic Acid TestNanosphere, Inc.20095—
+1K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention200859—
+1K081030Modification to Proflu+ AssayProdesse, Inc.200845—
+2K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc.20203—
+2K161220ARIES® Flu A/B & RSV AssayLuminex Corporation201601
+2K153219ProFlu+ AssayHologic, Inc.20151—
+2K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackFocus Diagnostics20141—
+2K142045Xpert Flu/RSV XC AssayCepheid20145—
+2K132237Prodesse Profast+ AssayGen-Probe Prodesse, Inc.20130—
+2K132129Prodesse Proflu+ AssayGen-Probe Prodesse, Inc.201313—
+2K120911Xpert Flu Genexpert DX Systems (GX-I, GX-IV)Cepheid20127—
+2K113323Artus Infl a/B RG RT-PCR KitQIAGEN GmbH20120—
+2K111778Jbaids Influenza a Subtyping KitU.S Army Medical Materiel Development Activity20110—
+2K111775Jbaids Influenza a&B Detection KitU.S. Army Medical Material Development Acitvity20111—
+2K111507CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201117—
+2K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc.2011184
+2K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc.201121
+2K100287Jbaids Influenza a/H5 Detection Kit, Model JRPD-Asy-0136U.S. Army Medical Material Development Command20100—
+2K101564CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR PanelCenters for Disease Control and Prevention201019—
+2K100148Simplexa Influenza a H1N1 (2009) Model MOL2500Focus Diagnostics, Inc.201034—
+2K092566Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)Nanosphere, Inc.20094—
+2K092500Modification to Proflu+ AssayProdesse, Inc.200941—
+2K083278Avc a/H5N1 Flu TestArbor Vita Corportation20090—
+3K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc.20260—
+3K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20211—
+3K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat SystemRoche Molecular Systems, Inc.20194—
+3K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion…Hologic, Inc.201701
+3K163628Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV20170—
+3K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20172—
+3K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20170—
+3K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid20154—
+3K152523JBAIDS Influenza A & B Detection KitU.S Army Medical Materiel Development Activity20150—
+3K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackFocus Diagnostics, Inc.201501
+3K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc.2014113
+3K131813Quidel Molecular RSV + HMPV AssayQuidel Corp.20137—
+3K131728Quidel Molecular Influenza a + B AssayQuidel Corp.20132—
+3K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc.20130—
+3K130551CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201315—
+3K122189Quidel Molecular RSV + HMPV AssayQuidel Corp.20130—
+3K123905CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention20130—
+3K123191Xpert FluCepheid20126—
+3K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.201204
+3K113777Quidel Molecular Influenza a+BQuidel Corp.20123—
+3K112172Quidel Molecular Influenza a + B AssayQuidel Corp.20113—
+4K230349Lyra RSV+hMPV AssayQuidel Corporation20230—
+4K230236Lyra Influenza A+B AssayQuidel Corporation20230—
+4K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20220—
+4K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20180—
+4K171641Accula Flu A/Flu B TestMesa Biotech, Inc.20180—
+4K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20171—
+4K171974Solana RSV+hMPV AssayQuidel Corporation20170—
+4K161814Solana Influenza A+B AssayQuidel Corporation20160—
+4K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc.201642
+4K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.20158—
+4K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc.20154—
+4K132508CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201314—
+5K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+5K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc.20167—
+5K141859CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5 SubtypingCenters for Disease Control and Prevention20149—
+5K140851Influenza a Subtyping Kit, CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention20149—
+5K140857Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-Time RT-PCR…Centers for Disease Control and Prevention20148—
+5K133869CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/B Typing KitCenter For Disease Control and Prevention (Cdc)20148—
+6K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+6K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+6K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.201761
+6K172091CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention20177—
+6K161556CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping KitCenters For Disease Control and Prevention (CDC)20168—
+6K153148CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 SubtypingCenters For Disease Control and Prevention (CDC)20158—
+7K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+7K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—
+7K190302CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention20195—
+7K181736CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage…Centers For Disease Control and Prevention (CDC)20186—
+8K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20252—
+8K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312
+8K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention202011
+9K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20251—
+9K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit…Centers for Disease Control and Prevention20240—
+10K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B…Centers for Disease Control and Prevention20260—