510(k) Report

Devices descending from K100148

34 later devices reach Simplexa Influenza a H1N1 (2009) Model MOL2500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103766Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software…Cepheid2011271
+1K101855Profast+ AssayGen-Probe Prodesse, Inc.20105—
+2K132237Prodesse Profast+ AssayGen-Probe Prodesse, Inc.20130—
+2K121003Abbott Plex-ID Flu AssayAbbott Laboratories20120—
+2K120911Xpert Flu Genexpert DX Systems (GX-I, GX-IV)Cepheid20127—
+2K111387Liat (TM) Influenza a / B Assay, Liat (TM) AnalyzerIquum, Inc.2011184
+2K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc.201121
+3K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat SystemRoche Molecular Systems, Inc.20194—
+3K163628Idylla Respiratory (IFV-RSV) PanelJanssen Pharmaceutica NV20170—
+3K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.20164—
+3K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc.2014113
+3K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc.20130—
+3K123191Xpert FluCepheid20126—
+4K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc.20203—
+4K171641Accula Flu A/Flu B TestMesa Biotech, Inc.20180—
+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—
+4K142045Xpert Flu/RSV XC AssayCepheid20145—
+5K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc.20260—
+5K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20211—
+5K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+5K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20172—
+5K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20170—
+5K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc.20167—
+5K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid20154—
+6K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+6K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20220—
+6K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+6K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20180—
+6K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20171—
+6K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.201761
+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—
+8K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312