K220026 is an FDA 510(k) clearance for the Genomadix Cube CYP2C19 System. This device is classified as a Drug Metabolizing Enzyme Genotyping Systems (Class II - Special Controls, product code NTI).
Submitted by Genomadix, Inc. (Kanata (Ottawa), CA). The FDA issued a Cleared decision on March 21, 2023, 440 days after receiving the submission on January 5, 2022.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3360. Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment Dose For Therapeutics That Are Metabolized Primarily By The Specific Enzyme Tested By The System..
| 510(k) Number | K220026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2022 |
| Decision Date | March 21, 2023 |
| Days to Decision | 440 days |
| Submission Type | Abbreviated |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | NTI - Drug Metabolizing Enzyme Genotyping Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3360 |
| Definition | Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment Dose For Therapeutics That Are Metabolized Primarily By The Specific Enzyme Tested By The System. |