Invader UGT1A1 Molecular Assay
FDA 510(k) K051824 · Third Wave Technologies, Inc.
510(k) numberK051824
Submission
- Device name
- Invader UGT1A1 Molecular Assay
- Applicant
- Third Wave Technologies, Inc.
Madison, WI, US - Received
- July 5, 2005
- Decision date
- August 18, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NTI – Drug Metabolizing Enzyme Genotyping Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3360
- Specialty
- Clinical Toxicology
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.
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| K043576 | Roche Amplichip CYP450 TestNTI · Traditional | Roche Molecular Systems, Inc. | 01/10/2005SE |
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Questions and answers
When was Invader UGT1A1 Molecular Assay cleared by the FDA?
Invader UGT1A1 Molecular Assay (K051824) received a 510(k) decision of Substantially Equivalent on August 18, 2005, 44 days after the submission was received.
What is the product code of K051824?
The FDA product code is NTI – Drug Metabolizing Enzyme Genotyping Systems, a Class II (moderate risk) device regulated under 21 CFR 862.3360.