510(k) · Cleared
ClearedGlutenID Celiac Genetic Health Risk Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Targeted Genomics, LLC · PTA Genetic Variant Detection And Health Risk Assessment System
Cleared on Jan 7, 2025 after a 230-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 7, 2025
- Review
- 230 days
- Class
- Class II
- Product code
- PTA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PTA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PTA device
- #1 K221420 AlphaID™ At Home Genetic Health Risk Servicescore 4.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PTA devicesPTA Genetic Variant Detection And Health Risk Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PTA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTA
Too few PTA 510(k)s in any year since 2007 to give a median.
Recalls per year · PTA
No recall names PTA since 2007.
Adverse event reports per year · PTA
1in 2024
MAUDE reports naming product code PTA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (127 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K241456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241456: GlutenID Celiac Genetic Health Risk Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241456
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026