DEN040011 is an FDA 510(k) submission for the AMPLICHIP CYP450 TEST, MODEL 04381866190. This device is classified as a Drug Metabolizing Enzyme Genotyping Systems (Class II - Special Controls, product code NTI).
Submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on December 23, 2004.
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 | DEN040011 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 20, 2004 |
| Decision Date | December 23, 2004 |
| Days to Decision | 3 days |
| Submission Type | Post-NSE |
| Review Panel | Chemistry (CH) |
| Summary | — |
| 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. |