Cleared Special

A1AT Genotyping Test

K192858 · Progenika Biopharma S.A., A Grifols Company · Immunology
Nov 2019
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K192858 is an FDA 510(k) clearance for the A1AT Genotyping Test, a Serpina1 Variant Detection System (Class II — Special Controls, product code PZH), submitted by Progenika Biopharma S.A., A Grifols Company (Derio, ES). The FDA issued a Cleared decision on November 5, 2019, 32 days after receiving the submission on October 4, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K192858 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2019
Decision Date November 05, 2019
Days to Decision 32 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code PZH — Serpina1 Variant Detection System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5130
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.