K130189 is an FDA 510(k) clearance for the XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE). This device is classified as a Drug Metabolizing Enzyme Genotyping Systems (Class II - Special Controls, product code NTI).
Submitted by Luminex Molecular Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on May 21, 2013, 116 days after receiving the submission on January 25, 2013.
This device falls under the Chemistry 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 | K130189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2013 |
| Decision Date | May 21, 2013 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| 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. |