# K182692: BD MAX CTGCTV2, BD MAX System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jan 8, 2019 after 103 days
- Product code: OUY (Trichomonas Vaginalis Nucleic Acid Amplification Test System)
- Device class: 2
- Regulation: 21 CFR 866.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K984631 (1999). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151589: BD Max CT/GC/TV, BD Max Instrument, Becton, Dickinson and Company (2016) Summary page 6.

## Most influential descendants
- K210585: BD CTGCTV2 (2022), 1 descendant of its own
- K243343: BD CTGCTV2 (2025), 0 descendants of its own
- K193081: Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit (2021), 0 descendants of its own

## Indications for use
The BD MAX™ CTGCTV2 assay, performed on the BD MAX™ System, incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from: e Chlamydia trachomatis (CT) e Neisseria gonorrhoeae (GC) e Trichomonas vaginalis (TV) The assay may be used for detection of CT, GC and/or TV DNA in patient- or clinician-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens. The assay may also be used for the detection of CT and GC DNA in endocervical swab and Liquid-Based Cytology (LBC) specimens in PreservCyt® Solution using an aliquot that is removed prior to processing for the ThinPrep™ Pap test. The assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of chlamydial urogenital disease, gonococcal urogenital disease and/or trichomoniasis. Ancillary Collection kits: The BD MAX 3-in-1 Swab Collection Kit is intended to be used in clinical settings according to the instructions provided for collection and transport of vaginal and endocervical swab specimens. This transport system is for use for testing with BD MAX products. The BD MAX Urine Transport Kit is intended to be used in clinical settings according to the instructions provided for collection, preservation and transport of urine specimens. This transport system is for use for testing with the BD MAX products. The BD MAX LBC Sample Buffer Tubes are intended to be used in clinical settings according to the instructions provided for the preservation and transport of Liquid-Based Cytology (LBC) specimens. This transport system is for use for testing with the BD MAX products.

Source page: https://510kreport.com/device/K182692
Methodology: https://510kreport.com/methodology