510(k) Report

Devices descending from DEN060008

64 later devices reach Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181205Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention20183—
+1K080570CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelCenters for Disease Control and Prevention200859—
+2K221658Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention20222—
+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—
+2K101855Profast+ AssayGen-Probe Prodesse, Inc.20105—
+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—
+2K083278Avc a/H5N1 Flu TestArbor Vita Corportation20090—
+3K221834Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention20221—
+3K152523JBAIDS Influenza A & B Detection KitU.S Army Medical Materiel Development Activity20150—
+3K132237Prodesse Profast+ AssayGen-Probe Prodesse, Inc.20130—
+3K130551CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201315—
+3K123905CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention20130—
+3K121003Abbott Plex-ID Flu AssayAbbott Laboratories20120—
+3K103766Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…Cepheid2011271
+3K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc.201121
+4K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and Prevention20220—
+4K163628Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV20170—
+4K132508CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and Prevention201314—
+4K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc.20130—
+4K120911Xpert Flu Genexpert DX Systems (GX-I, GX-IV)Cepheid20127—
+4K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc.2011184
+5K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat SystemRoche Molecular Systems, Inc.20194—
+5K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.20164—
+5K141859CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza a/H5 SubtypingCenters for Disease Control and Prevention20149—
+5K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc.2014113
+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—
+5K123191Xpert FluCepheid20126—
+6K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc.20203—
+6K171641Accula Flu A/Flu B TestMesa Biotech, Inc.20180—
+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—
+6K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.20158—
+6K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc.20154—
+6K142045Xpert Flu/RSV XC AssayCepheid20145—
+7K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc.20260—
+7K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20211—
+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—
+7K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+7K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20172—
+7K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20170—
+7K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc.20167—
+7K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid20154—
+8K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+8K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit…Centers for Disease Control and Prevention20252—
+8K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20220—
+8K200370CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit…Centers for Disease Control and Prevention202011
+8K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+8K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20180—
+8K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20171—
+8K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.201761
+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—
+9K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+9K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—
+10K263035CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B…Centers for Disease Control and Prevention20260—
+10K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312