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 T
| Device Type ID | 4929 |
| Device Name | Cancer Predisposition Risk Assessment System |
| Physical State | The Test System Consists Of Reagents, Instrumentation, Software, And Instructions Needed To Understand The Test Report. The Test System Includes A Collection Device, Instructions For Collecting The Specimen, And A Pre-addressed Shipping Label And Mat |
| Technical Method | The Test System Uses Multiplex Technology To Amplify, Detect, And Identify Nucleic Acid Variants Located In Specified Genes Associated With Hereditary Cancer Risk. Variants Are Identified By Comparison To A Specified Reference Sequence, And Genetic R |
| Target Area | Human Clinical Specimens (e.g., Saliva) Collected By The User/customer. |
| Regulation Medical Specialty | Molecular Genetics |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6090 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QAZ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4929 |
| Device | Cancer Predisposition Risk Assessment System |
| Product Code | QAZ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.6090 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
23ANDME, INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |