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510(k) K093974

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING by Osmetech Molecular Diagnostics — Product Code NPQ

K093974 is an FDA 510(k) premarket notification submitted by Osmetech Molecular Diagnostics for the device "ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING". The FDA issued a decision of Substantially Equivalent on April 22, 2010. The device falls under product code NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr), a Class II device regulated under 21 CFR 864.7280. Osmetech Molecular Diagnostics has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2010
Date Received
December 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device Class
Class II
Regulation Number
864.7280
Review Panel
PA
Submission Type

In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.

Other clearances by Osmetech Molecular Diagnostics

  • K090901 — ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING T (July 6, 2009)
  • K073720 — ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT (July 17, 2008)

Other clearances for product code NPQ

  • K100980 — INVADER FACTOR V (June 1, 2011)
  • K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (April 28, 2010)
  • K082118 — XPERT HEMOSIL FACTOR II & FACTOR V ASSAY (September 18, 2009)
  • K060564 — INFINITI SYSTEM (February 7, 2007)
  • DEN030005 — FACTOR V LEIDEN KIT (December 17, 2003)

FDA data resources