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cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231306

by Roche Molecular Systems, Inc.

Identifiers

510(k) Number
K231306 FDA 510(k)
FDA Product Code
QQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3981 FDA 510(k)
Regulation Number
866.3981 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in respiratory specimens. It is designed for use with nasopharyngeal swab specimens from individuals with signs and symptoms of COVID-19 and anterior nasal swab specimens from individuals with or without signs and symptoms of COVID-19, as well as healthcare provider-instructed self-collected anterior nasal swabs and provider-collected nasal, nasopharyngeal, and oropharyngeal swabs from any individuals.

The device is supplied for in vitro diagnostic use and is authorized under FDA 510(k) clearance (K231306). It is intended for use on the cobas 5800, 6800, and 8800 systems and is classified as a Class II device under regulation number 866.3981. The product is sterile, single-use, and stored under conditions specified by the manufacturer. No MRI safety information is provided in the data.

Frequently asked questions

What is the cobas SARS-CoV-2 Qualitative test used for?

The cobas SARS-CoV-2 Qualitative test is a real-time RT-PCR assay intended for the qualitative detection of nucleic acids from SARS-CoV-2 in respiratory specimens, including nasopharyngeal swabs from symptomatic individuals and anterior nasal swabs from symptomatic or asymptomatic individuals, as well as self-collected and provider-collected nasal, nasopharyngeal, and oropharyngeal swabs.

How is the cobas SARS-CoV-2 Qualitative test supplied and is it sterile or reusable?

The device is supplied for in vitro diagnostic use as a sterile, single-use test kit, meaning each unit is intended for one-time use only and must not be reprocessed or reused to avoid contamination or inaccurate results.

Which systems is the cobas SARS-CoV-2 Qualitative test compatible with and what is its regulatory classification?

The test is designed for use exclusively on the cobas 5800, 6800, and 8800 systems and is classified as a Class II medical device under FDA regulation number 866.3981, based on its substantial equivalence to a legally marketed predicate device.

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® SARS-CoV-2 Qualitative - Roche Diagnostics USA, cobas® SARS-COV-2, Qualitative assay for use on the cobas® 6800/8800 ..., MS - cobas 5800/6800/8800 SARS-CoV-2 Qualitative 192T, 480T (IVD ...

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) K231306 24 fields · synced Oct 6, 2026