Product Code: NTI FDA class 2 21 CFR 862.3360

Drug Metabolizing Enzyme Genotyping Systems

Clinical Toxicology

The Drug Metabolizing Enzyme Genotyping System is a molecular diagnostic device intended to identify the presence or absence of human genotypic markers encoding drug-metabolizing enzymes using DNA from clinical samples. Results can be used as an aid in determining treatment choice and individualizing drug dosing for therapeutics metabolized primarily by the enzyme being tested. It is an FDA Class 2 device regulated under 21 CFR 862.3360 in the Clinical Toxicology specialty, with product code NTI, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not provide life-sustaining support.

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510(k)s

FEI Numbers

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Basic Information

Product Code: NTI
Device Class: FDA class 2
Regulation Number: 862.3360
Medical Specialty: Clinical Toxicology
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K220026	Genomadix Cube CYP2C19 System	Mar 21, 2023	Substantially Equivalent	Genomadix, Inc.
K170492	xTAG CYP2D6 Kit v3	Aug 11, 2017	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.
K131565	XTAG CYP2C19 KIT V3	Sep 11, 2013	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.
K123891	SPARTAN RX CYP2C19 TEST SYSTEM	Aug 12, 2013	Substantially Equivalent	Spartan Bioscience, Inc.
K130189	XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)	May 21, 2013	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.
K120466	VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)	Nov 06, 2012	Substantially Equivalent	Nanosphere, Inc.
K101683	INFINITI CYP2C19 ASSAY	Oct 25, 2010	Substantially Equivalent	Autogenomics, Incorporated
K093420	XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)	Aug 26, 2010	Substantially Equivalent	Luminex Molecular Diagnostics, Inc.
K051824	INVADER UGT1A1 MOLECULAR ASSAY	Aug 18, 2005	Substantially Equivalent	Third Wave Technologies, Inc.
K043576	ROCHE AMPLICHIP CYP450 TEST	Jan 10, 2005	Substantially Equivalent	Roche Molecular Systems, Inc.
DEN040011	AMPLICHIP CYP450 TEST, MODEL 04381866190	Dec 23, 2004	Unknown	Roche Molecular Systems, Inc.