# PGE · Gastric Emptying Breath Test

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/PGE

## Overview

- **Product Code:** PGE
- **Device Name:** Gastric Emptying Breath Test
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P110015](/device/P110015.md) | GASTRIC EMPTYING BREATH TEST (GEBT) | Advanced Breath Diagnostics | Apr 6, 2015 | APPR |

## Top Applicants

- Advanced Breath Diagnostics — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/PGE](https://fda.innolitics.com/productcode/PGE)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com