510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130189Substantially Equivalent

Xtag Cyp2d6 Kit V3 (Including Tdas Cyp2d6 Software)

Luminex Molecular Diagnostics Inc, Toronto, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130189 is the FDA 510(k) clearance record for XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE), a class II device, cleared for Luminex Molecular Diagnostics, Inc. on under FDA product code NTI (Drug Metabolizing Enzyme Genotyping Systems). FDA's definition for product code NTI reads: "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...". FDA records list 26 510(k) clearances for Luminex Molecular Diagnostics, Inc., from to . As of , FDA records show no recalls naming K130189.

Clearance record

Decision date
Received
(116 days to decision)
Product code
NTI Drug Metabolizing Enzyme Genotyping Systems
Regulation
21 CFR 862.3360
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Luminex Molecular Diagnostics, Inc. 439 University Ave., Toronto, Ontario, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTI

Trailing 12 months

FDA records hold no clearances under product code NTI in the trailing twelve months.

FDA records show no clearances under product code NTI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260