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U.S. Department of Health and Human Services

Product Classification

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Device gastric emptying breath test
Definition Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal.
Physical State test kit, mass spectrometerSystem, 13C-labeled test meal, and associated software
Technical Method Baseline breath samples are collected prior to the administration of test meal. After an overnight fast, the patient consumes a 13C-labeled test meal and post-meal breath samples are collected at multiple time points after meal ingestion. As the meal is digested, 13CO2 is given off in the patient¿s breath. All pre- and post-meal breath samples are collectedand analyzed by a mass spectrometer to determine the ratio of 13CO2/12CO2 in each sample.
Target Area Breath samples from patients
Review Panel Toxicology
Product CodePGE
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible