510(k) K073720
K073720 is an FDA 510(k) premarket notification submitted by Osmetech Molecular Diagnostics for the device "ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT". The FDA issued a decision of Substantially Equivalent on July 17, 2008. The device falls under product code ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System), a Class II device regulated under 21 CFR 862.3360. Osmetech Molecular Diagnostics has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2008
- Date Received
- December 31, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- Device Class
- Class II
- Regulation Number
- 862.3360
- Review Panel
- TX
- Submission Type
An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.