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cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Ki…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190433

by Roche Molecular Systems, Inc.

Identifiers

510(k) Number
K190433 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 cobas TV/MG is a qualitative nucleic acid diagnostic test for use on the cobas 6800/8800 systems. It is an automated in vitro test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in male or female urine, self-collected vaginal swab specimens, or clinician-collected specimens.

The test is supplied as part of a system that includes the cobas TV/MG Positive Control Kit and cobas Buffer Negative Control Kit. It is intended for use in clinical settings and is regulated as a Class II device with FDA 510(k) clearance. The system consists of the sample supply module, transfer module, processing module, and analytic module, with automated data management performed by the cobas 6800/8800 software.

Frequently asked questions

What is the cobas TV/MG test used for?

The cobas TV/MG is a qualitative nucleic acid diagnostic test that detects DNA from Trichomonas vaginalis and Mycoplasma genitalium in male or female urine, self-collected vaginal swab specimens, or clinician-collected specimens.

How is the cobas TV/MG test supplied?

The test is supplied as part of a system that includes the cobas TV/MG Positive Control Kit and cobas Buffer Negative Control Kit, designed for use on cobas 6800/8800 systems with automated data management.

What specimens can be used with the cobas TV/MG test?

The test accepts male or female urine specimens, self-collected vaginal swabs, or clinician-collected specimens for the detection of Trichomonas vaginalis and Mycoplasma genitalium DNA.

What is the regulatory classification of the cobas TV/MG system?

The cobas TV/MG system is regulated as a Class II device with FDA 510(k) clearance, specifically for the detection of nucleic acids from non-viral microorganisms causing sexually transmitted infections.

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: cobas® TV/MG, Qualitative nucleic acid test for use on the cobas® 5800 ..., MS - cobas TV/MG (IVD) Qualitative nucleic acid test for use on the ..., cobas® TV/MG Test - Roche Diagnostics USA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Molecular Systems, Inc.

Sources (1)

  • FDA 510(k) K190433 24 fields · synced Oct 6, 2026