FDA product code OBZ: Alpha-1-Antitrypsin Kit, Qualitative Phenotype
OBZ is the FDA product code for alpha-1-antitrypsin kit, qualitative phenotype. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under OBZ, 1 in the last five years, from 2 different applicants. The average 510(k) review took 282 days (median 282).
Definition
The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.
Classification
| Field | Value |
|---|---|
| Device name | Alpha-1-Antitrypsin Kit, Qualitative Phenotype |
| Device class | Class II |
| Regulation | 21 CFR 866.5130 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OBZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 360 |
Compare with all 510(k) review times · Search every OBZ clearance
Top OBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories, Corp. | 1 | 2022-10-13 |
| Sebia | 1 | 2007-06-11 |
Most recent OBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213396 | Helena Laboratories, Corp. | SPIFE A1AT kit | 2022-10-13 | 360 |
| K063498 | Sebia | HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) | 2007-06-11 | 203 |
Recalls for OBZ devices
openFDA lists no recalls for product code OBZ.
Frequently asked questions
What is FDA product code OBZ?
OBZ is the FDA product code for alpha-1-antitrypsin kit, qualitative phenotype. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel.
What device class is OBZ?
Class II, regulation 21 CFR 866.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBZ?
Across 2 cleared submissions the average was 282 days from receipt to decision (median 282).
Which companies have the most OBZ clearances?
Helena Laboratories, Corp. (1); Sebia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OBZ
- Run a recall and safety report across every OBZ manufacturer
- Watch product code OBZ 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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