Definition: Autosomal Recessive Carrier Screening Gene Mutation Detection System Is A Qualitative In Vitro Molecular Diagnostic System Used For Genotyping Of Clinically Relevant Variants In Genomic DNA Isolated From Human Peripheral Whole Blood Or Saliva Specime
| Device Type ID | 4925 |
| Device Name | Autosomal Recessive Carrier Screening Gene Mutation Detection System |
| Physical State | Multiplex Microarray Based Detection System |
| Technical Method | Microarray Based Method To Detect Genomic DNA Mutations |
| Target Area | Human Clinical Specimens |
| Regulation Description | Autosomal Recessive Carrier Screening Gene Mutation Detection System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5940 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PKB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4925 |
| Device | Autosomal Recessive Carrier Screening Gene Mutation Detection System |
| Product Code | PKB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Autosomal Recessive Carrier Screening Gene Mutation Detection System. |
| CFR Regulation Number | 866.5940 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
23ANDME | ||
GRANTED | 1 | |