Cleared Traditional

GlutenID Celiac Genetic Health Risk Test

K241456 · Targeted Genomics, LLC · Immunology
Jan 2025
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K241456 is an FDA 510(k) clearance for the GlutenID Celiac Genetic Health Risk Test, a Genetic Variant Detection And Health Risk Assessment System (Class II — Special Controls, product code PTA), submitted by Targeted Genomics, LLC (Irvine, US). The FDA issued a Cleared decision on January 7, 2025, 230 days after receiving the submission on May 22, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5950.

Submission Details

510(k) Number K241456 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2024
Decision Date January 07, 2025
Days to Decision 230 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code PTA — Genetic Variant Detection And Health Risk Assessment System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5950
Definition A Qualitative In Vitro Molecular Test That Detects Variants In Genomic Dna Isolated From Human Specimens. This Assessment System Provides Users With A Genetic Health Risk Assessment Of Developing A Disease And Is Intended To Inform Users Of Lifestyle Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Person?s Overall Risk Of Developing A Disease.

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