Serpina1 Variant Detection System
The SERPINA1 Variant Detection System is a qualitative DNA in vitro diagnostic test for the simultaneous detection and identification of allelic variants in the SERPINA1 gene, which encodes the Alpha-1 antitrypsin (A1AT) protein, used alongside clinical findings and other laboratory tests to aid in the diagnosis of A1AT deficiency. It is classified as a Class 2 device under regulation 866.5130, requiring 510(k) premarket notification and eligible for third-party review, falling within the Immunology (IM) medical specialty. The product code is PZH. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZH
- Device Class
- FDA class 2
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211115 | A1AT Genotyping Test | May 13, 2021 | Substantially Equivalent | Progenika Biopharma S.A., A Grifols Company |
| K192858 | A1AT Genotyping Test | Nov 05, 2019 | Substantially Equivalent | Progenika Biopharma S.A., A Grifols Company |
| K171868 | A1AT Genotyping Test | Nov 11, 2017 | Substantially Equivalent | Progenika Biopharma S.A., A Grifols Company |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.