K223597 is an FDA 510(k) clearance for the 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). This device is classified as a Cancer Predisposition Risk Assessment System (Class II - Special Controls, product code QAZ).
Submitted by 23AndMe, Inc. (San Franciso, US). The FDA issued a Cleared decision on August 31, 2023, 272 days after receiving the submission on December 2, 2022.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 866.6090. A Qualitative In Vitro Molecular Diagnostic System Used For The Detection Of Select Variants In Specified Cancer-related Genes. The Device Is Intended To Be Used On Genomic Dna Isolated From Human Specimens Collected By The User. The Results Of The Test Provide Users With A Genetic Health Risk Assessment For Developing Certain Cancers. The Test May Not Include All Variants Associated With A Predisposition Of Developing Cancer And Is Not Intended To Describe A Persons Overall Risk Of Developing Any Type Of Cancer Nor To Aid In Determination Of Treatment Or Act As A Substitute For Recommended Cancer Screenings Or Appropriate Follow-up. The Device Is For Over-the-counter Use..
| 510(k) Number | K223597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2022 |
| Decision Date | August 31, 2023 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | QAZ - Cancer Predisposition Risk Assessment System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6090 |
| Definition | A Qualitative In Vitro Molecular Diagnostic System Used For The Detection Of Select Variants In Specified Cancer-related Genes. The Device Is Intended To Be Used On Genomic Dna Isolated From Human Specimens Collected By The User. The Results Of The Test Provide Users With A Genetic Health Risk Assessment For Developing Certain Cancers. The Test May Not Include All Variants Associated With A Predisposition Of Developing Cancer And Is Not Intended To Describe A Persons Overall Risk Of Developing Any Type Of Cancer Nor To Aid In Determination Of Treatment Or Act As A Substitute For Recommended Cancer Screenings Or Appropriate Follow-up. The Device Is For Over-the-counter Use. |