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Tuesday, September 24
Tue, Sep 24, 2:45 PM - 4:00 PM
Thurgood Marshall North
Diagnostic Devices with Intermediate/Gray Zone Output

Cardiovascular Devices with Non-Binary Decision (300953)

*Bipasa Biswas, FDA/CDRH 

Keywords: Diagnostic tests, intermediate zone

Medical diagnostic tests do not always yield a binary response- positive or negative result for a target condition. In some cases, the incorporation of an intermediate zone, leading to more than two results seems reasonable. The intermediate zone is important in some cases, as these zones indicate the need to obtain better information before ensuing therapy. Reporting the intermediate zone, using a 3x2 table is appropriate than ignoring it or using a hybrid approach. This presentation discusses available methods in literature for determining intermediate zone and the six-cell matrix (3x2 table) approach to a cardiovascular test.