510(k) K101683
K101683 is an FDA 510(k) premarket notification submitted by Autogenomics, Incorporated for the device "INFINITI CYP2C19 ASSAY". The FDA issued a decision of Substantially Equivalent on October 25, 2010. The device falls under product code NTI (Drug Metabolizing Enzyme Genotyping Systems), a Class II device regulated under 21 CFR 862.3360. Autogenomics, Incorporated has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2010
- Date Received
- June 15, 2010
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drug Metabolizing Enzyme Genotyping Systems
- Device Class
- Class II
- Regulation Number
- 862.3360
- Review Panel
- TX
- Submission Type
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.