COVID-19 (original) (raw)
As the pandemic becomes an endemic, we remain committed to utilizing our medical and scientific knowledge to offer healthcare solutions and maintain vigilance.
Product roadmap to IVD1
In vitro diagnostics (IVD) status: 510(k) clearance is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). De Novo approval is a request that provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA.
The current cobas SARS-CoV-2 EUA is not available on the cobas 5800.
In Q4 2024, we are working toward a flexible multiplex respiratory viral panel designed to support testing for SARS-CoV-2, Influenza A/B and RSV and 9 additional targets. This product is currently in development and not available in the U.S.
In vitro diagnostics (IVD) status: 510(k) clearance is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). De Novo approval is a request that provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA.
In vitro diagnostics (IVD) status: 510(k) clearance is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). De Novo approval is a request that provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA.
To learn more about Roche's COVID-19 portfolio, contact us.
Frequently asked questions
Frequently asked questions
Am I still able to use Roche’s products that are currently on the market under an EUA?
Yes, the PHE Declaration and the EUA declaration are separate. While the PHE ended May 11, 2023, and end date for the EUA Declaration has not yet been determined and communicated by the FDA. When the FDA announces the EUA termination date, labs should work with their manufacturer to understand the the path forward for each test they are utilizing.
When will the termination of the EUA Declaration happen?
The FDA has not announced when the EUA Declaration will be terminated.
Will Roche submit for clearance or approval for EUA products currently on the market?
Roche is fully committed to transitioning our EUA portfolio to IVD regulatory status to support testing across the continuum of care. The work has already begun, with two tests already receiving 510(k) clearance cobas® 6800/8800 SARS-CoV-2 Qualitative and cobas® liat SARS-CoV-2 & Flu A/B).
What is the estimated timeline for clearance or approval?
While we do not have a definitive timeline for receiving clearance or approval, Roche is working expeditiously to submit the COVID-19 products that are currently on the market under an EUA to the FDA.
Will Roche need to prepare a separate submission for the CLIA waiver on the cobas® liat SARS-CoV-2?
The cobas® liat SARS-CoV-2 assays were submitted for dual FDA 510(k) clearance to allow for the simultaneous 510(k) and CLIA waiver.
How is reimbursement affected?