IVD Medical Device Studies

We provide our partners in the biomedical manufacturing industry with a broad spectrum of laboratory services to assist in the preparation of IVD medical devices for timely, complete, and intelligently-supported FDA submissions. Our team performs both method comparison and precision testing to gather the data necessary to submit. We offer testing support for:

  • 510(k) Clearance
  • Premarket Approval (PMA)
  • De Novo Approval

Our partnerships with IVD medical device manufacturers are highly customized to support your specific needs, and can include the installation in our laboratory of any equipment/instrumentation relevant to your product development goals. We have over a decade of experience in offering personalized support for a wide range of research analyte categories, including, but not limited to, autoimmune conditions, biogenic amines and neurology, bone and mineral metabolism, brain disorders and neuroscience, cardiovascular markers, cytokines and cell signaling, diabetes and obesity, endocrinology and hormones, gastroenterology, immunology, infectious diseases, and oncology.

Customized full-service research
& diagnostic testing services

We help determine how your work compares to the market. 

As a researcher, you need to provide accurate data to prove your method can reliably yield the same results as other methods already accepted in the scientific community. Your work may be compared to a competitor's method or a previously accepted method of your own. At KMI Diagnostics, we provide the test data needed to support your claim that your new method is comparable.

We ensure your product’s consistency. 

Precision testing is a crucial component in justifying FDA approval.  It shows that, not only does the comparative method successfully yield the same result as an approved method, but that it does so repeatedly. At KMI Diagnostics, we provide your team with the specific precision testing needed in accordance with FDA requirements. This may include a process of tests conducted multiple times on the same run, over multiple shifts and/or days on separate runs, by different techs, and more to ensure your data is accurate and precise, regardless of outside factors.  

We decrease your time to market.

Our team prides itself on providing high-quality testing services and support to ensure projects are completed efficiently. Our testing services generate the accurate and timely data you need to complete your validation on schedule, including applicable performance verification and correlation studies relevant to the FDA submission process. 

At KMI Diagnostics, we can adapt to your team’s changing needs and respond quickly to new requests. Our results are also accompanied by raw data and QC assessment that illustrate our accuracy, precision, and attention to detail. 

The quality of our research support services is validated by our certified regulatory compliance, giving you the confidence to submit your work for FDA approval. 


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FDA Partner Case Study

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Hear From Our Partners

“Thank you for your exceptional customer service every step of the way. We were very pleased with your communication, dedication, and knowledge of methodology, and we are excited about the comprehensive results you provided us with.”

E Skornyakov,
Washington State University

“KMI Diagnostics provides an excellent service with a faster than expected turn-around time. Their professionalism and attentiveness to detail are unparalleled. It is always a pleasure to work with them and I would recommend them to anyone seeking replicable data for publication.”

A. Heuerman,
Loma Linda University

“Your services are always fast, efficient, and accurate along with friendly customer service! Thanks for the great experience!”

Harvard University

Personalized testing for FDA submission

    Start preparing for your FDA submission.