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U.S. Department of Health and Human Services

Product Classification
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Device test for esophageal varices
Definition A Test for Esophageal Varices is a quantitative test that measures cholate concentrations in human specimens and uses the cholate concentrations to generate a score. The score is used to identify patients unlikely to have large esophageal varices and unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing.
Physical State In vivo administration of cholates (via oral and intravenous routes) and in vitro diagnostic device to measure cholates in samples.
Technical Method The test system includes intravenous and oral administration of cholates, instruments, reagents, calibrators and controls for measuring cholate concentrations in samples and software to calculate a score from the cholate concentrations.
Target Area Human samples.
Review Panel Clinical Chemistry
Product CodeSIO
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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