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IVD Predicate Device Whitepaper

Selecting a lab partner for your 510(k) submission: 9 Key Considerations 

This whitepaper explores 9 key considerations IVD manufacturers should ask when selecting a lab testing partner, along with Quest’s responses. 
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Many IVD manufacturers know Quest Diagnostics as one of their largest customers. In fact, as the largest diagnostic lab in the country, we utilize instrumentation from nearly every IVD company in the market.

When IVD manufacturers develop new assays, they typically need to perform predicate device studies during the development and validation of new diagnostic tests. A predicate device study involves comparing the performance of a new test to that of a previously approved or cleared device that serves as a reference or "predicate" for the new device. The purpose of this study is to demonstrate that the new test is substantially equivalent to the predicate device in terms of performance, safety, and effectiveness.

This whitepaper is free and can be downloaded and read at your convenience.


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