Cleared Traditional

K171868 - A1AT Genotyping Test (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171868 · Progenika Biopharma S.A., A Grifols Company · Immunology device
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Nov 2017
Decision
142d
Days
Class 2
Risk

K171868 is an FDA 510(k) clearance for the A1AT Genotyping Test. Classified as Serpina1 Variant Detection System (product code PZH), Class II - Special Controls.

Submitted by Progenika Biopharma S.A., A Grifols Company (Derio, ES). The FDA issued a Cleared decision on November 11, 2017 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Progenika Biopharma S.A., A Grifols Company devices

Submission Details

510(k) Number K171868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2017
Decision Date November 11, 2017
Days to Decision 142 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 104d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PZH Serpina1 Variant Detection System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.