510(k) Report

Devices descending from K081030

45 later devices reach Modification to 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—
+1K153219ProFlu+ AssayHologic, Inc.20151—
+1K120413Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control PackFocus Diagnostics, Inc.201232
+1K110968Proflu+ AssayGen-Probe Prodesse, Inc.201115—
+1K102170Simplexa Flu a/B & RSVFocus Diagnostics, Inc.20100—
+1K101855Profast+ AssayGen-Probe Prodesse, Inc.20105—
+1K092500Modification to Proflu+ AssayProdesse, Inc.200941—
+1K083088Verigene Respiratory Virus Nucleic Acid TestNanosphere, Inc.20095—
+2K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc.20203—
+2K171963Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion…Hologic, Inc.201701
+2K161220ARIES® Flu A/B & RSV AssayLuminex Corporation201601
+2K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackFocus Diagnostics20141—
+2K142045Xpert Flu/RSV XC AssayCepheid20145—
+2K131813Quidel Molecular RSV + HMPV AssayQuidel Corp.20137—
+2K131728Quidel Molecular Influenza a + B AssayQuidel Corp.20132—
+2K132237Prodesse Profast+ AssayGen-Probe Prodesse, Inc.20130—
+2K132129Prodesse Proflu+ AssayGen-Probe Prodesse, Inc.201313—
+2K122189Quidel Molecular RSV + HMPV AssayQuidel Corp.20130—
+2K121003Abbott Plex-ID Flu AssayAbbott Laboratories20120—
+2K113777Quidel Molecular Influenza a+BQuidel Corp.20123—
+2K113323Artus Infl a/B RG RT-PCR KitQIAGEN GmbH20120—
+2K112172Quidel Molecular Influenza a + B AssayQuidel Corp.20113—
+2K103209Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)Nanosphere, Inc.201121
+2K092566Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)Nanosphere, Inc.20094—
+3K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc.20260—
+3K230349Lyra RSV+hMPV AssayQuidel Corporation20230—
+3K230236Lyra Influenza A+B AssayQuidel Corporation20230—
+3K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20211—
+3K171974Solana RSV+hMPV AssayQuidel Corporation20170—
+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—
+3K161814Solana Influenza A+B AssayQuidel Corporation20160—
+3K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc.201642
+3K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid20154—
+3K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackFocus Diagnostics, Inc.201501
+3K131584Imdx Flu a/B and RSV for Abbott M2000Intelligent Medical Devices, Inc.20130—
+3K123197Verigene C. Difficile Nucleic Acid Test (CDF)Nanosphere, Inc.201204
+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—
+4K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+4K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20171—
+5K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+5K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+6K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—