← Back to catalogue

cobas liat CT/NG/MG nucleic acid test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240197

by Roche Molecular Systems, Inc.

Identifiers

510(k) Number
K240197 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)

This device is a Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections. It is designed to detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) from patient specimens.

The test is supplied as an in vitro diagnostic reagent kit for use with the cobas liat system. It is intended for use in clinical laboratory settings and has received FDA 510(k) clearance under product code QEP and regulation number 866.3393.

Frequently asked questions

What is the cobas® liat CT/NG/MG nucleic acid test used for?

It is used to detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium from patient specimens as a nucleic acid detection system for non-viral microorganisms causing sexually transmitted infections.

How is the cobas® liat CT/NG/MG nucleic acid test supplied and what system is it used with?

It is supplied as an in vitro diagnostic reagent kit designed for use with the cobas liat system in clinical laboratory settings.

What regulatory pathway was used for the cobas® liat CT/NG/MG nucleic acid test?

The device received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device under product code QEP and regulation number 866.3393.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Roche Molecular Systems, Inc.

Sources (1)

  • FDA 510(k) K240197 24 fields · synced Sep 23, 2026