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FDA 510(k)

GlutenID Celiac Genetic Health Risk Test

K-Number: K241456 · 2025-01-07

ApplicantTargeted Genomics, LLC
Decision Date2025-01-07
Product CodePTA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GlutenID Celiac Genetic Health Risk Test is a medical device manufactured by Targeted Genomics, LLC. It received FDA 510(k) clearance on 2025-01-07 under approval number K241456. The device is classified under product code PTA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GlutenID Celiac Genetic Health Risk Test?

GlutenID Celiac Genetic Health Risk Test is a medical device that received FDA 510(k) clearance on 2025-01-07. It is manufactured by Targeted Genomics, LLC. The 510(k) number is K241456.

When was GlutenID Celiac Genetic Health Risk Test approved by the FDA?

GlutenID Celiac Genetic Health Risk Test received FDA 510(k) clearance on 2025-01-07, under approval number K241456.

What company makes GlutenID Celiac Genetic Health Risk Test?

GlutenID Celiac Genetic Health Risk Test is manufactured by Targeted Genomics, LLC.

What is the FDA product code for GlutenID Celiac Genetic Health Risk Test?

The FDA product code for GlutenID Celiac Genetic Health Risk Test is PTA.

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Related PubMed Literature

PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 39900769 Regulatory Perspectives for Gene Expression-Based Diagnostic Devices. Methods in molecular biology (Clifton, N.J.) (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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