PZH · Serpina1 Variant Detection System
Immunology · 21 CFR 866.5130 · Class 2
Overview
| Product Code | PZH |
|---|---|
| Device Name | Serpina1 Variant Detection System |
| Regulation | 21 CFR 866.5130 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, alpha-1-antitrypsin deficiency has been associated with pulmonary emphysema.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K211115 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | May 13, 2021 | SESE |
| K192858 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | Nov 5, 2019 | SESE |
| K171868 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | Nov 11, 2017 | SESE |
Top Applicants
- Progenika Biopharma S.A., A Grifols Company — 3 clearances
