# K241456: GlutenID Celiac Genetic Health Risk Test

- Pathway: 510(k) (Traditional)
- Applicant: Targeted Genomics, LLC
- Decided: Jan 7, 2025 after 230 days
- Product code: PTA (Genetic Variant Detection And Health Risk Assessment System)
- Device class: 2
- Regulation: 21 CFR 866.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from saliva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR). 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. This report is most relevant for people of European descent.

Source page: https://510kreport.com/device/K241456
Methodology: https://510kreport.com/methodology