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U.S. Department of Health and Human Services

Product Classification

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Device serpina1 variant detection system
Regulation Description Alpha-1-antitrypsin immunological test system.
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.
Physical State Qualitative in vitro molecular diagnostic system used to detect variants in SERPINA1 gene in genomic DNA isolated from human specimens. The accompanying software application is used to view and analyze genotype data and conducts a variety of control checks on the file, resulting in a final analytical genotype profile for each sample.
Technical Method Qualitative in vitro molecular diagnostic system used to detect variants in SERPINA1 gene in genomic DNA isolated from human specimens. The results of this assessment system are to be used in conjunction with clinical findings and other laboratory tests to aid in diagnosis of A1AT deficiency.
Target Area Human specimens
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodePZH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5130
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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