510(k) Report

Devices descending from K850291

22 later devices reach Mueller Hinton Agar W/4% Nacl W/Antibiotics through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090301Binaxnow PBP2A Test, Model 890-000Binax, Inc.20101—
+1K091766Clearview Exact PBP2A Test, Model 891-000Binax, Inc.20104—
+1K033415Idi-MrsaInfectio Diagnostic (I.D.I.), Inc.2004141
+2K162385Rapidec Carba NPBiomerieux S.A.20172—
+2K140619Meca XpressfishAdvandx, Inc.20140—
+2K121905Alere PBP2A TestAlere Scarborough, Inc.20120—
+2K102740Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt)…bioMerieux, Inc.20110—
+2K091409Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727Roche Molecular Systems, Inc.20101—
+2K070462Xpert MrsaCepheid2007101
+3K191889NG-Test CARBA 5Ng Biotech20191—
+3K142721cobas MRSA/SA TestRoche Molecular Systems, Inc.201401
+3K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.)200972
+3K080837Xpert Mrsa/SA Ssti AssayCepheid20081—
+4K243499NG-Test® CTX-M MULTINg Biotech20250—
+4K243625Xpert MRSA/SA SSTICepheid®20240—
+4K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc)201244
+4K112937Mrsa/SA Elite MGBElitech20121—
+5K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc.201321
+5K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+5K132468Mrsa/SA Elite MGB, Elite MGB SoftwareElitechgroup Epoch Biosciences20130—
+6K191742ARIES MRSA AssayLuminex Corporation20190—
+6K162444Xpert MRSA NxGCepheid20160—