13C-Spirulina Gastric Emptying Breath Test (GEBT)
FDA PMAEUDAMEDClass III (US FDA PMA)
Identity
- Trade Name
- GASTRIC EMPTYING BREATH TEST (GEBT) FDA PMA
- Generic Name
- Gastric Emptying Breath Test FDA PMA
Identifiers
- PMA Number
- P110015 FDA PMA
- FDA Product Code
- PGE FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Clinical Chemistry FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The 13C‑Spirulina Gastric Emptying Breath Test (GEBT) is a diagnostic system that measures the rate of gastric emptying of solid meals in adult humans. It utilizes a gas isotope‑ratio mass spectrometer (GIRMS) to determine the ratio of ^13CO₂ to ^12CO₂ in breath samples, providing quantitative data on gastric motility.
The test is performed with a specific GEBT test meal and must be administered under the supervision of a health‑care professional, although no specialized facilities or specially licensed personnel are required. The device is classified as a Class III medical device and has received FDA PMA and IVDR authorizations (PMA number P110015, product code PGE).
Frequently asked questions
What is the primary clinical use of the 13C-Spirulina Gastric Emptying Breath Test (GEBT) and how does it work?
The 13C-Spirulina GEBT is designed to measure the rate at which solid meals empty from the stomach in adult humans. It works by using a gas isotope-ratio mass spectrometer (GIRMS) to analyze breath samples for the ratio of ^13CO₂ to ^12CO₂ after ingestion of a specialized test meal containing ^13C-labeled spirulina. This ratio helps quantify gastric motility and aids in diagnosing delayed gastric emptying (gastroparesis) in symptomatic adults. The test requires healthcare supervision but does not need specialized facilities or licensed personnel beyond standard clinical settings.
Is the 13C-Spirulina GEBT a single-use or reusable device, and how is it supplied?
The 13C-Spirulina GEBT is a diagnostic system that includes a gas isotope-ratio mass spectrometer (GIRMS) and a test meal, but the core analytical instrument (GIRMS) is not described as single-use. The test meal itself is likely single-use per protocol, as it is consumed by the patient during the procedure. The device is supplied as a complete system for measuring gastric emptying, including the necessary components for breath sample analysis and the labeled test meal, though exact packaging details (e.g., kits, cartridges) are not specified in the data.
What regulatory pathways has the 13C-Spirulina GEBT followed, and what does this mean for its use?
The 13C-Spirulina GEBT has received FDA Premarket Approval (PMA) under PMA number P110015 and is classified as an IVDR-authorized device in Europe. This means it has undergone rigorous review to demonstrate safety and effectiveness for its intended use—measuring gastric emptying of solids and aiding in diagnosing gastroparesis in symptomatic adults. The approvals confirm the device meets regulatory standards for clinical use in these contexts.
Does the 13C-Spirulina GEBT require specialized training or equipment beyond standard clinical settings?
No specialized facilities or licensed personnel are required beyond standard clinical supervision. While the test must be administered under the oversight of a healthcare professional, the procedure does not mandate additional infrastructure or training beyond what is typically available in diagnostic or gastroenterology settings. The device itself relies on a GIRMS for breath analysis, which is part of the system’s design but does not necessitate extra qualifications for the administering clinician.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: A Stable Isotope Breath Test with a Standard Meal for ... - PMC, Cairn Diagnostics: Home, Utility of a 13 C-Spirulina Stable Isotope Gastric Emptying ..., Gastric Emptying Breath Test - U.S. Pharmacist, Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P110015 | Class III | Active |
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Manufacturer
- Manufacturer
- Advanced Breath Diagnostics
Sources (2)
- FDA PMA P110015 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 19, 2026