510(k) Report

Devices descending from K081824

9 later devices reach BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151589BD Max CT/GC/TV, BD Max InstrumentBecton, Dickinson and Company201662
+1K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO20140—
+1K090824BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO20090—
+2K202977Alinity m STI AssayAbbott Molecular, Inc.20221—
+2K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company20193—
+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—
+4K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,20250—