Cleared Traditional

K241456 - GlutenID Celiac Genetic Health Risk Test (FDA 510(k) Clearance)

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

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

K241456 is an FDA 510(k) clearance for the GlutenID Celiac Genetic Health Risk Test. Classified as Genetic Variant Detection And Health Risk Assessment System (product code PTA), Class II - Special Controls.

Submitted by Targeted Genomics, LLC (Irvine, US). The FDA issued a Cleared decision on January 7, 2025 after a review of 230 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5950 - 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 Targeted Genomics, LLC devices

Submission Details

510(k) Number K241456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 104d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PTA Genetic Variant Detection And Health Risk Assessment System
Device Class Class 2 - 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.
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.

Regulatory Consultant

Medical Device Academy, Inc.
Bhoomika Joyappa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.