FDA product code OBE: Anti-Ss-A 52 Autoantibodies
OBE is the FDA product code for anti-ss-a 52 autoantibodies. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under OBE, 1 in the last five years, from 2 different applicants. The average 510(k) review took 267 days (median 258); 417 days on average over the last three years.
Definition
The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Ss-A 52 Autoantibodies |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OBE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 417 |
Compare with all 510(k) review times · Search every OBE clearance
Top OBE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 2 | 2015-03-05 |
| Zeus Scientific | 1 | 2026-05-08 |
Most recent OBE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250814 | Zeus Scientific | Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB | 2026-05-08 | 417 |
| K141655 | Inova Diagnostics, Inc. | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS | 2015-03-05 | 258 |
| K063565 | Inova Diagnostics, Inc. | QUANTA LITE SS-A 52 ELISA | 2007-04-04 | 127 |
Recalls for OBE devices
openFDA lists no recalls for product code OBE.
Frequently asked questions
What is FDA product code OBE?
OBE is the FDA product code for anti-ss-a 52 autoantibodies. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is OBE?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBE?
Across 3 cleared submissions the average was 267 days from receipt to decision (median 258).
Which companies have the most OBE clearances?
Inova Diagnostics, Inc. (2); Zeus Scientific (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OBE
- Run a recall and safety report across every OBE manufacturer
- Watch product code OBE 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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