A1AT Genotyping Test

Basic Information

• Brand Name: A1AT Genotyping Test
• Primary DI: 08437013457101
• Version / Model: 48 Tests
• Catalog Number: 1292320000
• Company Name: PROGENIKA BIOPHARMA, SA
• Labeler DUNS: 464176127
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-14
• Public Version: 1
• Public Version Date: 2023-07-24
• Public Version Status: New
• Public Device Record Key: d7a9cfee-8b5f-4712-88ee-d5e5b4bceaa8

Device Description

The A1AT Genotyping Test uses Polymerase Chain Reaction (PCR) amplification to obtain large amounts of the target sequences in the serpin peptidase inhibitor class A member 1 (SERPINA1) gene. The A1AT Genotyping Test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. A1AT Genotyping Test generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is allelic variant genotypes and associated alleles. A1AT genotyping Test simultaneously detects and identifies 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in K2-EDTA or from human saliva samples collected as buccal swabs using ORAcollect Dx OCD-100. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZH	Serpina1 Variant Detection System	Immunology	866.5130	2
PTA	Genetic Variant Detection And Health Risk Assessment System	Immunology	866.5950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59278	Alpha-1-antitrypsin deficiency IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic condition alpha-1-antitrypsin deficiency, associated with mutation in the SERPINA1 gene, using a nucleic acid technique (NAT). Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437013457101	GS1

Premarket Submissions

Submission Number	Supplement Number
K211115	000
K221420	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius