| Device |
test, volatile organic compounds breath analysis |
| Definition |
Aid in the diagnosis of grade 3 heart transplant rejection in patients who have received heart transplants within the preceding year. Intended to be used as an adjunct to, and not as a substitute for, endomyocardial biopsy. The use of the device is limited to patients who have had endomyocardial biopsy within the previous month. |
| Physical State |
A breath collection apparatus for collection of volatile organic compounds in alveolar breath onto a sorbent trap, as well as for the collection of a separate sample of room air. o Analysis of the volatile organic compounds in alveolar breath and room air by gas chromatography and mass spectroscopy. o Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of grade 3 heart transplant rejection. |
| Technical Method |
Breathe collection device; analysis of the volatile organic compounds in alveolar breath and room air by gas chromatography and mass spectroscopy |
| Target Area |
Patients with heart transplants |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | PAR |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
