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Wednesday, September 27
Wed, Sep 27, 10:45 AM - 12:00 PM
Thurgood Marshall North
Parallel Session: Statistical Challenges for Medical Tests with Reference Databases

Reference Databases in in Vivo Diagnostic Devices (300455)

*Bipasa Biswas, FDA/CDRH 

Keywords: reference database, quantitative test

Clinical laboratory tests often require a reference interval for quantitative tests and the construction of such intervals are common for laboratory tests. In vivo diagnostic devices in ophthalmology or neurology utilize reference database (also commonly known as normative database) to compare an individual patient’s medical device output/result against the reference database for clinical management of the individual patient. This talk will discuss issues related to subject selection, important co-variate, presentation and use of results from a reference database.