510(k) Report

Devices descending from K022504

17 later devices reach Idi-Strep B Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062948Smart GBS and Smartcycle DX System and Software, Version 1.7BCepheid200614—
+1K060540Xpert, Genexpert DX SystemCepheid200611
+2K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheid20230—
+2K121539Xpert GBS LB Genexpert DX Systems (GX-I, GX-IV) Genexpert DX Systems (GX-Xvi) Genexpert…Cepheid20122—
+2K112125Illumigene Group B Streptococcus ,External Control KitMeridian Bioscience, Inc.20114—
+2K1023143M Integrated Cycler (110V) & (220V)Focus Diagnostics, Inc.20100—
+2K090191Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip, Handylab…Handylab, Inc.20104—
+3K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid20220—
+3K181156Panther Fusion GBS AssayDiagenode201802
+3K173725NeuMoDx GBS AssayNeumodx Molecular, Inc.20180—
+3K143312Portrait GBS AssayGreat Basin Corporation20150—
+3K133503Amplivue GBS AssayQuidel Corporation20131—
+3K121044Illumigene Group B Streptococcus Carrot Broth ClaimMeridian Bioscience, Inc.201201
+3K111860BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO201227
+4K173250Solana GBS AssayQuidel Corporation20170—
+4K170557GenePOC GBS LBGenepoc, Inc.20171—
+5K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC20180—