Device Trials

400 FDA submissions and counting.

Rigorous testing and analysis by leading experts so you can pave the way to a healthier future.

• Completion of FDA submission protocols per your needs
• Accessible in-house principal investigators with expertise in all clinical and anatomic pathology disciplines
• Abilities to engage non-laboratory professionals for true “point-of-care” evaluations
• Research staff certified in Human Research Subject Protection
• Experienced research technologists and coordinators
• GCP-certified scientists and technologists
• Extended lab hours
• Fast turnaround with study start-up
• Access to large and diverse quantity of predicate methods

A modular clinical chemistry and immunochemistry analyzer beside blood collection tubes.


May 14, 2024

Point of Care Testing: A Blessing or a Burden?

Point-of-care testing (POCT) refers to medical diagnostic testing that is performed near the patient, often at the bedside, rather than in a centralized laboratory. This type of testing provides rapid results, allowing healthcare providers to make immediate treatment decisions. POCT devices are typically portable, easy to use, and require minimal training. They are suitable for…

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December 11, 2023

New Areas of Discovery and Collaboration

Since its inception, TriCore’s Research Institute has experienced steady and continuous growth, emphasizing research in the field of infectious diseases. During the pandemic, the focus was on COVID Emergency Use Authorizations, which were crucial. The Institute is now diversifying to encompass more intricate studies, such as more complex COVID 510(k) submissions and other respiratory viruses….

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November 13, 2023

TRI Partners with Sponsors for 510(k) Submissions

A 510(k) submission is a premarket submission made to the U.S. Food and Drug Administration (FDA) for the purpose of obtaining clearance to market a medical device or instrument in the United States. An in-vitro diagnostic (IVD) medical device manufacturer may need to submit a 510(k) application if it intends to introduce a new IVD…

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