K043576 is an FDA 510(k) clearance for the ROCHE AMPLICHIP CYP450 TEST. 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 Cleared decision on January 10, 2005, 14 days after receiving the submission on December 27, 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 | K043576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2004 |
| Decision Date | January 10, 2005 |
| Days to Decision | 14 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. |