510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070804Substantially Equivalent

Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test

Luminex Corporation, Northbrook IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070804 is the FDA 510(k) clearance record for VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST, a class II device, cleared for Nanosphere, Inc. on under FDA product code ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System). FDA's definition for product code ODW reads: "An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized...". FDA records list 34 510(k) clearances for Luminex Corporation, from to . As of , FDA records show one recall naming K070804.

Clearance record

Decision date
Received
(178 days to decision)
Product code
ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Regulation
21 CFR 862.3360
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Nanosphere, Inc. 4088 Commercial Ave., Northbrook IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODW

Trailing 12 months

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

FDA records show no clearances under product code ODW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODW, 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