510(k) Report

Devices descending from K062440

16 later devices reach Gen-Probe Aptima Assay for Neisseria Gonorrhoeae, Model 1091 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091724BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO200913—
+1K091730BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO2009131
+1K090827BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO200901
+2K191352binx health io CT/NG AssayBinx Health, Inc.20191—
+2K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc.2012102
+3K200533binx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc.202001
+3K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.20177—
+3K140887Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20140—
+3K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20139—
+4K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20186—
+5K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20250—
+5K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20250—
+5K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20213—
+6K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…Roche Molecular Systems, Inc.20260—
+6K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20260—
+6K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20260—