Genetic health risk · 510(k) K241456

GlutenID: Celiac disease (HLA-DQ)

FDA record K241456: 510(k) cleared on January 7, 2025 for Targeted Genomics. It was decided after FDA last updated its Direct-to-Consumer Tests table (December 20, 2019); it appears in FDA's device database.

FDA recordK241456

FDA device name

GlutenID Celiac Genetic Health Risk Test

Applicant (as FDA lists it)

Targeted Genomics, LLC

FDA decision

Substantially equivalent (cleared)

Decision date

January 7, 2025 (received May 22, 2024)

Product code

PTA

Regulation

21 CFR 866.5950

FDA database entry · FDA 510(k) file (PDF) · openFDA record

What the authorization says it may report

The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLA-DQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype.

The report describes if a person has variants linked to haplotypes associated with an increased risk for developing celiac disease, but it does not describe a person’s overall risk of developing celiac disease.

Genes or markers named: HLA-DQ2.5, HLA-DQ8, HLA-DQ7, HLA-DQ2.2

Stated limitations

We didn't find limitation statements in this FDA file beyond the indications quoted above.

FDA classifies this test type under 21 CFR 866.5950, which says: “This assessment system is for over-the-counter use. This device does not determine the person's overall risk of developing a disease.” (21 CFR 866.5950)

What this record doesn't tell you

An FDA record says what a test was authorized to report on the decision date. It doesn't say whether the product is still sold, what it costs, or which version a kit in a store uses. Check the company's own label and report for the current claims.

FDA's general advice on direct-to-consumer tests: “Do not make any dietary or health-related decisions without first discussing your test results with your health care provider.” (U.S. Food and Drug Administration) On disease-risk results: “Remember that a positive result from a test does not mean that you will develop that disease or condition.” (U.S. Food and Drug Administration)

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About genetic health risk tests · All FDA records