510(k) Report

Devices descending from K070462

10 later devices reach Xpert Mrsa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093346BD Geneohm Mrsa Acp AssayBd Diagnostics (Geneohm Sciences, Inc.)200972
+1K080837Xpert Mrsa/SA Ssti AssayCepheid20081—
+2K243625Xpert MRSA/SA SSTICepheid®20240—
+2K120138BD Max Mrsa Assay, BD Max InstrumentBd Diagnostics (Geneohm Sciences Canada, Inc)201244
+2K112937Mrsa/SA Elite MGBElitech20121—
+3K133605BD Max Mrsa XT, BD Max InstrumentGeneohm Sciences Canada, Inc.201321
+3K132822BD Max Staphsr Assay, InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics)201302
+3K132468Mrsa/SA Elite MGB, Elite MGB SoftwareElitechgroup Epoch Biosciences20130—
+4K191742ARIES MRSA AssayLuminex Corporation20190—
+4K162444Xpert MRSA NxGCepheid20160—