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 S
| Device Type ID | 6296 |
| Device Name | Gastric Emptying Breath Test |
| Physical State | Test Kit, Mass SpectrometerSystem, 13C-labeled Test Meal, And Associated Software |
| Technical Method | 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 |
| Target Area | Breath Samples From Patients |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PGE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |