FDA product code SIO: Test For Esophageal Varices
SIO is the FDA product code for test for esophageal varices. It is a Class III device, reviewed by the Clinical Chemistry panel. Devices under SIO reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A Test for Esophageal Varices is a quantitative test that measures cholate concentrations in human specimens and uses the cholate concentrations to generate a score. The score is used to identify patients unlikely to have large esophageal varices and unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing.
Classification
| Field | Value |
|---|---|
| Device name | Test For Esophageal Varices |
| Device class | Class III |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SIO devices
openFDA lists no recalls for product code SIO.
Frequently asked questions
What is FDA product code SIO?
SIO is the FDA product code for test for esophageal varices. It is a Class III device, reviewed by the Clinical Chemistry panel.
What device class is SIO?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SIO
- Run a recall and safety report across every SIO manufacturer
- Watch product code SIO 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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