# K210585: BD CTGCTV2

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: May 10, 2022 after 438 days
- Product code: QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections)
- Device class: 2
- Regulation: 21 CFR 866.3393
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K984631 (1999). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182692: BD MAX CTGCTV2, BD MAX System, Becton, Dickinson and Company (2019) Summary page 5.

## Most influential descendants
- K243343: BD CTGCTV2 (2025), 0 descendants of its own

## Recalls of this device
- Oct 31, 2024 · Class II · Z-0588-2025: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are 

## Indications for use
The BD CTGCTV2 assay incorporates automated DNA extraction and real-time polymerase chain reaction (PCR) for the direct, qualitative detection of DNA from: • Chlamydia trachomatis (CT) • Neisseria gonorrhoeae (GC) • 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 ThinPrep 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. The BD CTGCTV2 assay is available for use on the BD MAX System or the BD COR System.

Source page: https://510kreport.com/device/K210585
Methodology: https://510kreport.com/methodology