510(k) Report

Devices descending from K081825

26 later devices reach BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company201662
+1K140447BD Viper LT SystemBecton, Dickinson and Company201402
+1K140448BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO20140—
+1K091724BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO200913—
+1K091730BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO2009131
+1K090971BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO200901
+1K090827BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO200901
+2K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+2K191352binx health io CT/NG AssayBinx Health, Inc.20191—
+2K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company20193—
+2K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc.2012102
+3K222379Alinity m STI AssayAbbott Molecular, Inc.202301
+3K210585BD CTGCTV2Becton, Dickinson and Company202211
+3K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software)…Rheonix, Inc.20210—
+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—
+4K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,20250—
+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—