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510(k) K070804

VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST by Nanosphere, Inc. — Product Code ODW

K070804 is an FDA 510(k) premarket notification submitted by Nanosphere, Inc. for the device "VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST". The FDA issued a decision of Substantially Equivalent on September 17, 2007. The device falls under product code ODW (Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System), a Class II device regulated under 21 CFR 862.3360. Nanosphere, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2007
Date Received
March 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device Class
Class II
Regulation Number
862.3360
Review Panel
TX
Submission Type

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 by the CYP2C9 gene product.

Other clearances by Nanosphere, Inc.

  • K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (September 4, 2015)
  • K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (June 20, 2014)
  • K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
  • K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (December 5, 2012)
  • K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
  • K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
  • DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)
  • K112424 — VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) (December 16, 2011)
  • K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (January 10, 2011)
  • K093337 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (November 17, 2009)

Other clearances for product code ODW

  • K183530 — TruDiagnosis System (May 24, 2019)
  • K152612 — eSensor Warfarin Sensitivity Saliva Test (May 26, 2016)
  • K073071 — EQ-PRC LC WARFARIN GENOTYPING KIT (February 6, 2009)
  • K073720 — ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (July 17, 2008)
  • K073014 — INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN (January 23, 2008)

FDA data resources