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NTI — Drug Metabolizing Enzyme Genotyping Systems Class II

FDA Device Classification

Classification Details

Product Code
NTI
Device Class
Class II
Regulation Number
862.3360
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220026genomadixGenomadix Cube CYP2C19 SystemMarch 21, 2023
K170492luminex molecular diagnosticsxTAG CYP2D6 Kit v3August 11, 2017
K131565luminex molecular diagnosticsXTAG CYP2C19 KIT V3September 11, 2013
K123891spartan bioscienceSPARTAN RX CYP2C19 TEST SYSTEMAugust 12, 2013
K130189luminex molecular diagnosticsXTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)May 21, 2013
K120466nanosphereVERIGENE CYP2C19 NUCLEIC ACID TES (2C19)November 6, 2012
K101683autogenomics, incorporatedINFINITI CYP2C19 ASSAYOctober 25, 2010
K093420luminex molecular diagnosticsXTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0August 26, 2010
K051824third wave technologiesINVADER UGT1A1 MOLECULAR ASSAYAugust 18, 2005
K043576roche molecular systemsROCHE AMPLICHIP CYP450 TESTJanuary 10, 2005
DEN040011roche molecular systemsAMPLICHIP CYP450 TEST, MODEL 04381866190December 23, 2004