A1AT Genotyping Test
by Progenika Biopharma S.A., A Grifols Company 3 variants
510(k) K211115
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK211115 | Date13 May 2021 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- PZH
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5130
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The A1AT Genotyping Test is an in vitro diagnostic device used for detecting genetic variants of the Serpina1 gene, specifically for identifying mutations associated with Alpha-1 Antitrypsin (A1AT) deficiency. This test falls under the classification of a Serpina1 Variant Detection System, enabling precise genetic analysis to support clinical diagnosis and risk assessment for hereditary conditions linked to A1AT deficiency.
This device is intended for use in clinical laboratories and is supplied as a reagent kit for molecular analysis. It is classified as a Class II in vitro diagnostic medical device under FDA regulations and is compliant with the In Vitro Diagnostic Regulation (IVDR). The test requires specialized laboratory equipment and trained personnel for processing, with no specific sterility requirements beyond standard aseptic handling for molecular assays. Authorizations include FDA 510(k) clearance (K211115) and IVDR conformity assessment.
Other devices from Progenika Biopharma S.A., A Grifols Company
Questions
AI-generated answers, 18 Sep 2026
What clinical conditions is the A1AT Genotyping Test designed to help diagnose or assess risk for?
The A1AT Genotyping Test is specifically designed to detect genetic variants of the *Serpina1* gene that are linked to Alpha-1 Antitrypsin (A1AT) deficiency. This hereditary condition can increase the risk of lung diseases (such as emphysema) and liver disorders, so the test supports clinical diagnosis and risk assessment for these conditions by identifying mutations associated with the deficiency.
How is the A1AT Genotyping Test supplied, and what kind of laboratory setup is required to use it?
The test is supplied as a reagent kit for molecular analysis, meaning it comes with all necessary components for genetic testing in a clinical lab. It requires specialized laboratory equipment and trained personnel to process samples, as it involves molecular techniques to detect *Serpina1* gene variants. No additional sterility measures beyond standard aseptic handling for molecular assays are specified.
Is the A1AT Genotyping Test intended for single-use or can it be reused across multiple tests?
The test is designed as a reagent kit for molecular analysis, which implies it is intended for single-use per test run. Reagent kits in molecular diagnostics are typically consumed during a single procedure to ensure accuracy and prevent cross-contamination, though the exact usage instructions should be followed as per the manufacturer’s guidelines.
What regulatory pathways has the A1AT Genotyping Test undergone, and which agencies have approved it?
The test has received FDA 510(k) clearance under the reference number *K211115*, confirming it is classified as substantially equivalent to a predicate device. It is also compliant with the In Vitro Diagnostic Regulation (IVDR), ensuring it meets European Union standards for in vitro diagnostics. Both authorizations validate its use for detecting *Serpina1* gene variants in clinical settings.