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13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

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Generic:Gastric Emptying Breath Test
Manufacturer:advanced breath diagnostics
Drug Classes:Not Available
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13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

Generic:Gastric Emptying Breath Test
Manufacturer:advanced breath diagnostics
Drug Classes:Not Available
Reps:
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Synopsis
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DescriptionIndication and UsageContraindications
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Synopsis
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13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
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Disclaimer: The synopsis and product information provided on Alpha.MD are derived from openFDA data and are for informational purposes only. This information may not be comprehensive, accurate, or up-to-date. Clinicians should exercise their own professional judgment in interpreting and using this information, and consult the official prescribing information for the most accurate and current details.
Description

The Gastric Emptying Breath Test (GEBT) is a non-radioactive, non-invasive, orally administered test for measurement of the rate of solid phase gastric emptying in adults. The GEBT has been validated against the reference method of gastric scintigraphy. The GEBT utilizes the stable isotope carbon-13, denoted as 13C. The GEBT may be administered in a primary care facility, clinic or tertiary care setting. The GEBT measures how fast the stomach empties solids after ingestion of a cooked egg test meal, labeled with 13C-Spirulina particles. The GEBT procedure is conducted over a 4 hour period. Following an overnight (or ≥8 hour) fast, duplicate pre-meal breath samples are collected from the test subject (used to establish a subject’s baseline 13CO2 level). Following pre-meal breath sample collection, the subject is administered the test meal. Single post- meal breath samples are subsequently collected at 45, 90, 120, 150, 180, and 240 minutes from the end of test meal consumption. Breath samples, collected in capped glass tubes before and after test meal administration, are returned to a central laboratory for analysis by Gas Isotope Ratio Mass Spectrometry (GIRMS) to determine the ratio of 13CO2/12CO2 in each sample. By measuring the change in this ratio over time as compared to the pre-meal value, the rate of 13CO2 excretion can be calculated and the individual’s gastric emptying rate determined. The key components of the GEBT system include:  GEBT Kit (See table below)  GIRMS System: The Automated Breath Carbon Analyzer (ABCA) is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS) System intended for use in the measurement the carbon content of breath samples (13CO2/12CO2 ratio) collected as part of the GEBT procedure. Component Description Test Meal [ 13C]-GEBT Diagnostic Dosage: Polyethylene-lined foil pouch of Smoke- Flavored Scrambled Egg Mix containing 43 mg 13C in approximately 100 mg [13C]-Spirulina platensis with oxygen absorber Cracker Package: Six (6) Nabisco PREMIUM saltine crackers (3 two- cracker packs) in a heat-sealed foil pouch containing an O2 absorber Meal Preparation Components Plastic cutlery – Pre-packaged plastic knife and fork, pre-packaged plastic spoon Filling Cup – 3 fl. oz. plastic cup for transferring potable water Cooking Cup – 8 oz. plastic cup for cooking the egg mix GEBT Administration Instructions Breath Collection Assembly Eight (8) glass breath collection tubes with screw-caps – Exetainer® brand, 510(k) K880622; Labco, Ltd., Establishment Reg. #8021930 Two (2) wrapped plastic drinking straws Breath sample transport container and pre-addressed overnight courier pack Packaging Device Box – corrugated cardboar d, white exterior, houses ALL components Meal Kit Box – corrugated cardboard, white exterior, houses test meal and test meal preparation components Breath Collection Tube Transport Container – white polyethylene foam insert with detachable cardboard sleeve, houses glass breath collection tubes

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Indication and Usage

The Gastric Emptying Breath Test (GEBT), to be used with the GEBT test meal, is 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. For these purposes, the test system utilizes a Gas Isotope Ratio Mass Spectrometer (GIRMS) for the measurement of the ratio of 13CO2 to 12CO2 in breath samples. The GEBT procedure should be administered under supervision of a health care professional although no specialized facilities or specially licensed personnel are required.

Contraindications

 Individuals with known hypersensitivity to Spirulina, egg, milk or wheat allergens should avoid the GEBT.  Because the GEBT is an indirect multi-compartmental method of measuring gastric emptying, GEBT results may be inaccurate in individuals compromised with significant small bowel, pancreatic, liver and/or lung disease. Consequently GEBT should not be administered to patients with pulmonary dysfunction (e.g. COPD) and/or small bowel malabsorption.

Approval History
FDA approved 2018
Includes history for all formulations of adalimumab
July 12, 2018
(Type 2 New Active Ingredient and Type 4 New Combination)
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