510(k) Report

Devices descending from DEN140005

23 later devices reach Lyra Direct Strep Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162274Solana Strep Complete AssayQuidel Corporation20160—
+1K150868Solana GAS Assay, Solana instrumentQuidel Corporation20150—
+1K141757Alere I Strep aAlere Scarborough, Inc.20158—
+1K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc.20151Class I
+1K141338Liat Strep a AssayIquum, Inc.20148—
+1K141173Amplivue Gas AssayQuidel Corporation20140—
+2K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLC20260—
+2K201269Accula Strep A TestMesa Biotech, Inc.20200—
+2K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc.20203—
+2K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.20183—
+2K173398Xpert Xpress Strep ACepheid20180—
+2K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex Corporation201701
+2K172126Xpert Xpress Strep ACepheid201702
+2K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc.20154—
+3K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc.20260—
+3K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+3K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20211—
+3K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+4K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+4K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312
+4K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20220—
+4K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+5K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—