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PZH — Serpina1 Variant Detection System Class II

FDA Device Classification

Classification Details

Product Code
PZH
Device Class
Class II
Regulation Number
866.5130
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K211115progenika biopharma s.a., a grifolsA1AT Genotyping TestMay 13, 2021
K192858progenika biopharma s.a., a grifolsA1AT Genotyping TestNovember 5, 2019
K171868progenika biopharma s.a., a grifolsA1AT Genotyping TestNovember 11, 2017