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U.S. Department of Health and Human Services

Product Classification

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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 CodePAR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE - Humanitarian Device Exemption
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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