Home / 510(k) Clearances / K051824

510(k) K051824

INVADER UGT1A1 MOLECULAR ASSAY by Third Wave Technologies, Inc. — Product Code NTI

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.

Other clearances by Third Wave Technologies, Inc.

  • K063787 — INPLEX CF MOLECULAR TEST (March 13, 2008)

Other clearances for product code NTI

  • K220026 — Genomadix Cube CYP2C19 System (March 21, 2023)
  • 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)
  • K043576 — ROCHE AMPLICHIP CYP450 TEST (January 10, 2005)
  • DEN040011 — AMPLICHIP CYP450 TEST, MODEL 04381866190 (December 23, 2004)