FDA product code OPX: Immunoglobulin A Kappa Heavy & Light Chain Combined
OPX is the FDA product code for immunoglobulin a kappa heavy & light chain combined. It is a Class II device, regulated under 21 CFR 866.5510 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under OPX, from 2 different applicants. The average 510(k) review took 92 days (median 84).
Definition
Intended for the in-vitro quantification of iga kappa 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 | Immunoglobulin A Kappa 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 |
Compare with all 510(k) review times · Search every OPX clearance
Top OPX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 2016-06-16 |
| The Binding Site | 1 | 2014-03-18 |
Most recent OPX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160819 | The Binding Site Group , Ltd. | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | 2016-06-16 | 84 |
| K151759 | The Binding Site Group , Ltd. | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | 2015-11-06 | 130 |
| K140105 | The Binding Site | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | 2014-03-18 | 62 |
Recalls for OPX devices
openFDA lists no recalls for product code OPX.
Frequently asked questions
What is FDA product code OPX?
OPX is the FDA product code for immunoglobulin a kappa 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 OPX?
Class II, regulation 21 CFR 866.5510. Typical premarket route: 510(k).
How long does a 510(k) take for product code OPX?
Across 3 cleared submissions the average was 92 days from receipt to decision (median 84).
Which companies have the most OPX clearances?
The Binding Site Group , Ltd. (2); The Binding Site (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OPX
- Run a recall and safety report across every OPX manufacturer
- Watch product code OPX 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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