FDA product code PGE: Gastric Emptying Breath Test
PGE is the FDA product code for gastric emptying breath test. It is a Class III device, reviewed by the Clinical Toxicology panel. Devices under PGE reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for PGE devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Gastric Emptying Breath Test |
| Device class | Class III |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PGE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-01-08.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code PGE?
PGE is the FDA product code for gastric emptying breath test. It is a Class III device, reviewed by the Clinical Toxicology panel.
What device class is PGE?
Class III. Typical premarket route: PMA.
Have PGE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-01-08.
Next steps
- Run an FDA pathway report with predicate devices for product code PGE
- Run a recall and safety report across every PGE manufacturer
- Watch product code PGE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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