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510(k) K220026

Genomadix Cube CYP2C19 System by Genomadix, Inc. — Product Code NTI

K220026 is an FDA 510(k) premarket notification submitted by Genomadix, Inc. for the device "Genomadix Cube CYP2C19 System". The FDA issued a decision of Substantially Equivalent on March 21, 2023. The device falls under product code NTI (Drug Metabolizing Enzyme Genotyping Systems), a Class II device regulated under 21 CFR 862.3360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2023
Date Received
January 5, 2022
Clearance Type
Abbreviated
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.

Other clearances for product code NTI

  • K170492 — xTAG CYP2D6 Kit v3 (August 11, 2017)
  • K131565 — XTAG CYP2C19 KIT V3 (September 11, 2013)
  • K123891 — SPARTAN RX CYP2C19 TEST SYSTEM (August 12, 2013)
  • K130189 — XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE) (May 21, 2013)
  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
  • K101683 — INFINITI CYP2C19 ASSAY (October 25, 2010)
  • K093420 — XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0 (August 26, 2010)
  • K051824 — INVADER UGT1A1 MOLECULAR ASSAY (August 18, 2005)
  • K043576 — ROCHE AMPLICHIP CYP450 TEST (January 10, 2005)
  • DEN040011 — AMPLICHIP CYP450 TEST, MODEL 04381866190 (December 23, 2004)

FDA data resources