K241456 is an FDA 510(k) clearance for the GlutenID Celiac Genetic Health Risk Test. This device is classified as a Genetic Variant Detection And Health Risk Assessment System (Class II - Special Controls, product code PTA).
Submitted by Targeted Genomics, LLC (Irvine, US). The FDA issued a Cleared decision on January 7, 2025, 230 days after receiving the submission on May 22, 2024.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5950. A Qualitative In Vitro Molecular Test That Detects Variants In Genomic Dna Isolated From Human Specimens. This Assessment System Provides Users With A Genetic Health Risk Assessment Of Developing A Disease And Is Intended To Inform Users Of Lifestyle Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Persons Overall Risk Of Developing A Disease..
| 510(k) Number | K241456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2024 |
| Decision Date | January 07, 2025 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | PTA - Genetic Variant Detection And Health Risk Assessment System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5950 |
| Definition | A Qualitative In Vitro Molecular Test That Detects Variants In Genomic Dna Isolated From Human Specimens. This Assessment System Provides Users With A Genetic Health Risk Assessment Of Developing A Disease And Is Intended To Inform Users Of Lifestyle Choices And/or Encourage Conversations With A Healthcare Professional. This Assessment System Is For Over-the-counter Use. This Device Does Not Determine The Persons Overall Risk Of Developing A Disease. |