FDA product code PAR: Test, Volatile Organic Compounds Breath Analysis
PAR is the FDA product code for test, volatile organic compounds breath analysis. It is a HDE device, reviewed by the Clinical Chemistry panel. Devices under PAR reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Test, Volatile Organic Compounds Breath Analysis |
| Device class | HDE |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for PAR devices
openFDA lists no recalls for product code PAR.
Frequently asked questions
What is FDA product code PAR?
PAR is the FDA product code for test, volatile organic compounds breath analysis. It is a HDE device, reviewed by the Clinical Chemistry panel.
What device class is PAR?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code PAR
- Run a recall and safety report across every PAR manufacturer
- Watch product code PAR 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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