510(k) Submissions for FDA Enable Market Access for Customer Products
Through the COVID-19 pandemic, we assisted customers with their work to move diagnostic devices through the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) process, enabling temporary market access. Today, those same customers are interested in achieving permanent market access through the FDA’s 510(k) approval process. Per FDA, “A 510(k) 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.”
Recognizing customer need for 510(k) submissions for FDA, we have developed and now opened a new laboratory that hosts the specialized instrumentation necessary to support the process at a world-class level. To learn about the laboratory and its capabilities, we spoke with MRIGlobal’s Bobby Krumsick, Capability Manager, Life Sciences, who has been leading development of this new space.
What prompted development of this new space?
Through the COVID-19 pandemic, we worked with many customers in the preparation of their Emergency Use Authorization (EUA) submissions for FDA, enabling market access for their pandemic-related products. As those same customers now seek full product approval, it is important that we provide them the space, instrumentation, and expertise of our team to facilitate the process. Additionally, as new disease outbreaks occur, such as the recent mpox (formerly known as “Monkeypox”) outbreak, clients reach out to MRIGlobal for help with their clinical comparator testing. This necessitates bringing on-board new instrumentation that can meet these constantly evolving needs.
Why was it important to find the right laboratory space for the equipment?
The past few years, MRIGlobal has brought multiple clinical comparator platforms on-board. These include Hologic Panther Fusion®, BioFire FilmArray® Torch, Cepheid GeneXpert®, bioMérieux’s EMAG® and easyMag® (Quidel® Lyra assays). To further expand our reference lab capability and offer our customers the most frequently sought-after, gold standard clinical comparator platforms, we have added the Roche Diagnostics cobas® 6800 to our CAP/CLIA laboratory. Because of the importance of this work, it was key that we not just find enough square footage to hold such a large instrument and its ancillary equipment, but design a laboratory space that is specifically built for it. Once we identified the best possible space in our Kansas City facility, we quickly began planning and renovations to prepare for delivery of the instrument.
This new laboratory has now been built to accommodate this highly sought-after clinical comparator testing platform, functioning as a complement to our existing CAP/CLIA laboratories.
Can you tell me about the laboratory’s instrumentation?
The instrument this lab was built for is the Roche Diagnostics cobas® 6800, which is a fully automated, highly sensitive, sample to answer platform capable of running more than 20 Roche diagnostic assays. These include respiratory, blood-borne disease, sexual health, and transplant assays. The instrument also comes with a unique cobas® omni Utility Channel that enables users to develop and add their own third-part tests and Laboratory Developed Tests (LDTs).
Who will work in this new laboratory?
A few months ago, a member of our team completed training on the instrument at Roche headquarters, enabling us to prepare instrument specific SOPs prior to instrument installation. Now, our CAP/CLIA trained staff will participate in multiple days of rigorous vendor-led training and competency assessments on the new instrumentation.
What advantages does this laboratory provide our customers?
The instrumentation in this laboratory is absolutely the best in the world, supporting our team and customers in their development of 510(k) submissions for FDA, enabling market access for their products. The developer of this instrumentation has built a reputation for responding quickly to evolving public health needs by developing high quality assays in a very timely manner. The recent 510(k) clearance of the SARS-CoV-2 assay, and the Emergency Use Authorization for the mpox assay on the cobas® 6800 has further cemented the instrument platform as the gold-standard for FDA clinical comparator testing.
Having this instrumentation on board, we now have the flexibility to work on many different diseases and evaluate a variety of different products, including antigen tests and full-size sample enhancer molecular tests. This will help our customers prepare for the future and address whatever the next emerging infectious disease is.
What has the customer reception been thus far?
Customer response has been very positive, as we were very successful at shepherding through their EUA submissions by navigating the complexities of the FDA, and the 510(k) is now the next step in approval. We’re already scheduling use of the laboratory and team for the coming months.
GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal to further understand our work in infectious diseases. We offer a broad portfolio of infectious disease testing assays and capabilities across diagnostic disciplines, from screening and diagnosis to genotyping, therapy, and monitoring. Those seeking support to advance the research, development, and validation of infectious disease tests can trust in our breadth of experience and knowledge – not just on the subject matter, but FDA protocols as well.
To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.
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