K211499 is an FDA 510(k) clearance for the 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related). 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 January 6, 2022, 237 days after receiving the submission on May 14, 2021.
This device falls under the Medical Genetics 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 | K211499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2021 |
| Decision Date | January 06, 2022 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Medical Genetics (MG) |
| 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. |