510(k) K051824
K051824 is an FDA 510(k) premarket notification submitted by Third Wave Technologies, Inc. for the device "INVADER UGT1A1 MOLECULAR ASSAY". The FDA issued a decision of Substantially Equivalent on August 18, 2005. The device falls under product code NTI (Drug Metabolizing Enzyme Genotyping Systems), a Class II device regulated under 21 CFR 862.3360. Third Wave Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2005
- Date Received
- July 5, 2005
- Clearance Type
- Traditional
- 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.