510(k) Report

Devices descending from K042357

19 later devices reach Idi-Mrsa Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091409Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727Roche Molecular Systems, Inc.20101—
+1K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.)200972
+1K071026BD Geneohm Staphsr AssayBd Diagnostics (Geneohm Sciences Canada, Inc)20079—
+2K142721cobas MRSA/SA TestRoche Molecular Systems, Inc.201401
+2K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+2K130894Xpert Mrsa/SA Blood Culture Assay; Genexpert DX Systems (GX-I, GX-II, GX-IV, GX-Xvi)…Cepheid20131—
+2K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc)201244
+2K112937Mrsa/SA Elite MGBElitech20121—
+2K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc.20111—
+2K082140Xpert Mrsa/SA Blood Culture AssayCepheid200832
+2K080837Xpert Mrsa/SA Ssti AssayCepheid20081—
+3K243625Xpert MRSA/SA SSTICepheid®20240—
+3K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System…Cepheid20190—
+3K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc.201321
+3K132468Mrsa/SA Elite MGB, Elite MGB SoftwareElitechgroup Epoch Biosciences20130—
+3K120563Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc.20120—
+3K101879Xpert Mrsa/SA BC (Blood Culture) Assay Model Gxmrsa/SA-BC-10Cepheid201021
+4K191742ARIES MRSA AssayLuminex Corporation20190—
+4K162444Xpert MRSA NxGCepheid20160—