13C-Spirulina Gastric Emptying Breath Test (GEBT)

13C
13C-Spirulina GEBT - K021

A collection of devices intended to be used for the breath analysis of a carbon isotope (e.g., carbon-13, carbon-14) to investigate suspected gastrointestinal disorders [e.g., gastric emptying disorder (gastroparesis), H. pylori infection]. It consists of an ingestible carbon isotope-labelled substrate and breath specimen containers or collection card. The test relies on the metabolism of the substrate and expiration of carbon isotopes in CO2. It can be administered by a healthcare professional in a clinical setting or alternatively by the patient at home, for subsequent analysis in a clinical laboratory or at the point-of-care. This is a single-use device.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PGE

Device Name: Gastric Emptying Breath Test

Device Class: 3

Physical State: test kit, mass spectrometerSystem, 13C-labeled test meal, and associated software

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.

Submission Type ID: 2

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: 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.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Breath samples from patients

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: M763K0211

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A