Cleared Special

K192858 - A1AT Genotyping Test (FDA 510(k) Clearance)

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K192858 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 5, 2019 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K192858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 104d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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.