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510(k) K093129

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II by Illumina, Inc. — Product Code NPQ

K093129 is an FDA 510(k) premarket notification submitted by Illumina, Inc. for the device "ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II". The FDA issued a decision of Substantially Equivalent on April 28, 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. Illumina, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2010
Date Received
October 2, 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 Illumina, Inc.

  • DEN130042 — MISEQDX UNIVERSAL KIT 1.0 (November 19, 2013)
  • DEN130011 — ILLUMINA MISEQDX PLATFORM (November 19, 2013)
  • K132750 — ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (November 19, 2013)
  • K124006 — ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (November 19, 2013)
  • K093128 — ILLUMINA BEADXPRESS SYSTEM (April 28, 2010)

Other clearances for product code NPQ

  • K100980 — INVADER FACTOR V (June 1, 2011)
  • K093974 — ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII G (April 22, 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