510(k) K183530
K183530 is an FDA 510(k) premarket notification submitted by Akonni Biosystems, Inc. for the device "TruDiagnosis System". The FDA issued a decision of Substantially Equivalent on May 24, 2019. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2019
- Date Received
- December 19, 2018
- 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.