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BD CTGCTV2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210585

by Becton, Dickinson and Company

Identifiers

510(k) Number
K210585 FDA 510(k)
FDA Product Code
QEP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3393 FDA 510(k)
Regulation Number
866.3393 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD CTGCTV2 is a Nucleic Acid Detection System designed for identifying non-viral microorganisms causing sexually transmitted infections. It employs molecular diagnostics to detect specific genetic material from pathogens such as Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, enabling rapid and accurate diagnostic testing in clinical microbiology settings.

This system is intended for use in clinical laboratories and is supplied as a disposable cartridge for integration with the BD MAX System. It is sterile, single-use, and requires no special handling beyond standard molecular assay protocols. The device is classified as a Class II medical device under FDA regulations (product code QEP) and has received FDA 510(k) clearance through the Traditional pathway. Storage and handling comply with standard molecular assay protocols, and its performance is validated for diagnostic use in microbiology.

Frequently asked questions

What types of sexually transmitted infections can the BD CTGCTV2 detect, and how does it work?

The BD CTGCTV2 is designed to detect specific genetic material from three non-viral pathogens: *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, and *Trichomonas vaginalis*. It uses molecular diagnostics—specifically nucleic acid detection—to identify these microorganisms in clinical samples, enabling rapid and accurate diagnosis in microbiology laboratories. The system relies on the BD MAX platform, which processes disposable cartridges containing the assay reagents.

Is the BD CTGCTV2 cartridge reusable, or is it intended for single-use only?

The BD CTGCTV2 cartridge is explicitly designed for single-use only. It is sterile and meant to be integrated into the BD MAX System for one diagnostic test per cartridge. No special handling beyond standard molecular assay protocols is required, but reuse would compromise sterility and accuracy, so it is not recommended.

How should the BD CTGCTV2 be stored, and are there any special handling requirements?

Storage and handling of the BD CTGCTV2 follow standard molecular assay protocols. Since it is a sterile, single-use cartridge, it should be stored in a clean, dry environment protected from physical damage or contamination. Avoid exposure to extreme temperatures or direct sunlight. The system is validated for diagnostic use in microbiology settings, so adherence to manufacturer guidelines for the BD MAX platform is advised to maintain performance.

What regulatory pathway was used for FDA clearance of the BD CTGCTV2, and what does that mean for its use?

The BD CTGCTV2 received FDA clearance through the Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it against existing, legally marketed devices in the same category (product code QEP) and found it to meet safety and effectiveness standards for use in clinical microbiology laboratories. The clearance does not imply any specific clinical indication but confirms the device’s compliance with FDA requirements for nucleic acid detection systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K210585 FDA 510(k) - BD CTGCTV2 | Becton, Dickinson and Company, BD (company) - Wikipedia, PDF BD CTGCTV2 for BD MAX System, Becton Dickinson – Wikipedia, BD MAX CTGCTV2, BD MAX System (K182692) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K210585 24 fields · synced Sep 18, 2026