510(k) Report

Devices descending from K003395

42 later devices reach Gen-Probe Aptima Combo 2 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081824BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO20089—
+1K081825BD Probetec Neisseria Gonorrhoeae (GC) Q Amplified Dna AssayBecton, Dickinson & CO2008261
+1K043224Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc.200521—
+1K032554Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc.20031—
+2K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company201662
+2K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO20140—
+2K140447BD Viper LT SystemBecton, Dickinson and Company201402
+2K140448BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO20140—
+2K121710Xpert CT/NGCepheid201273
+2K092704Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…Abbott Molecular, Inc.2010111
+2K091724BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO200913—
+2K091730BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO2009131
+2K090971BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO200901
+2K090824BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO20090—
+2K090827BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO200901
+2K080739Abbott Realtime CT/NG Assay and Multi-Collect Specimen Collection KitAbbott Molecular, Inc.20080—
+3K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+3K200748Visby Medical Sexual HealthVisby Medical20212—
+3K191352binx health io CT/NG AssayBinx Health, Inc.20191—
+3K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company20193—
+3K173840Xpert CT/NGCepheid20181—
+3K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…Cepheid20154—
+3K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc.2012102
+4K220407Visby Medical Sexual Health TestVisby Medical20231—
+4K222379Alinity m STI AssayAbbott Molecular, Inc.202301
+4K210585BD CTGCTV2Becton, Dickinson and Company202211
+4K193081Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software)…Rheonix, Inc.20210—
+4K200533binx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc.202001
+4K190441Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80…Cepheid20190—
+4K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.20177—
+4K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…Cepheid20160—
+4K140887Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20140—
+4K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc.20139—
+5K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.20250—
+5K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,20250—
+5K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20186—
+6K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20250—
+6K240197cobas® liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20250—
+6K202408cobas CTNG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.20213—
+7K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…Roche Molecular Systems, Inc.20260—
+7K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.20260—
+7K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.20260—