K-number	K241456
Device name	GlutenID Celiac Genetic Health Risk Test
Applicant	Targeted Genomics, LLC
Product code	PTA
Device class	Class II
Decision date	Jan 7, 2025
Decision	Substantially Equivalent
Regulation	866.5950

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The GlutenID Celiac Genetic Health Risk Test performs qualitative genotyping on DNA from saliva samples to detect HLA variants associated with celiac disease risk. It analyzes variants in the HLA-DQ2.5, HLA-DQ8, HLA-DQ7, and HLA-DQ2.2 haplotypes and reports whether a person carries genetic variants linked to increased celiac disease risk, intended for over-the-counter use in individuals 18 years or older of European descent.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document concludes substantial equivalence was determined but does not provide the specific reasoning, predicate device comparison, or technical arguments supporting that determination in the available pages.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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GlutenID Celiac Genetic Health Risk Test

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