Cleared Special

A1AT Genotyping Test

K211115 · Progenika Biopharma S.A., A Grifols Company · Immunology
May 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K211115 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 May 13, 2021, 29 days after receiving the submission on April 14, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5130.

Submission Details

510(k) Number K211115 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2021
Decision Date May 13, 2021
Days to Decision 29 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.