FDA product code PZH: Serpina1 Variant Detection System
PZH is the FDA product code for serpina1 variant detection system. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under PZH. The average 510(k) review took 68 days (median 32).
Definition
This is a qualitative DNA detection in vitro diagnostic test to be used in conjunction with a visualization instrument and its software. This test is for the simultaneous detection and identification of allelic variants found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. This assessment system provides users with genetic information regarding genotypes of SERPINA1 allelic variants and is intended to be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of individuals with A1AT deficiency.
Classification
| Field | Value |
|---|---|
| Device name | Serpina1 Variant Detection System |
| 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 PZH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 142 |
| 2019 | 1 | 32 |
| 2021 | 1 | 29 |
Compare with all 510(k) review times · Search every PZH clearance
Top PZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Progenika Biopharma S.A., A Grifols Company | 3 | 2021-05-13 |
Most recent PZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211115 | Progenika Biopharma S.A., A Grifols Company | A1AT Genotyping Test | 2021-05-13 | 29 |
| K192858 | Progenika Biopharma S.A., A Grifols Company | A1AT Genotyping Test | 2019-11-05 | 32 |
| K171868 | Progenika Biopharma S.A., A Grifols Company | A1AT Genotyping Test | 2017-11-11 | 142 |
Recalls for PZH devices
openFDA lists no recalls for product code PZH.
Frequently asked questions
What is FDA product code PZH?
PZH is the FDA product code for serpina1 variant detection system. It is a Class II device, regulated under 21 CFR 866.5130 and reviewed by the Immunology panel.
What device class is PZH?
Class II, regulation 21 CFR 866.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code PZH?
Across 3 cleared submissions the average was 68 days from receipt to decision (median 32).
Which companies have the most PZH clearances?
Progenika Biopharma S.A., A Grifols Company (3).
Next steps
- Run an FDA pathway report with predicate devices for product code PZH
- Run a recall and safety report across every PZH manufacturer
- Watch product code PZH 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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