FDA product code OPY: Igal Heavy & Light Chain Combined
OPY is the FDA product code for igal heavy & light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. Devices under OPY reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Intended for the in-vitro quantification of iga lambda concentration in human serum. The result is to be used with previously diagnosed iga multiple myeloma, in conjunction with other clinical and laboratory findings. For previously diagnosed iga multiple myeloma patients.
Classification
| Field | Value |
|---|---|
| Device name | Igal Heavy & Light Chain Combined |
| Device class | Class II |
| Regulation | 21 CFR 866.5510 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for OPY devices
openFDA lists no recalls for product code OPY.
Frequently asked questions
What is FDA product code OPY?
OPY is the FDA product code for igal heavy & light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel.
What device class is OPY?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OPY
- Run a recall and safety report across every OPY manufacturer
- Watch product code OPY 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.