Illumina Verncode Genotyping Test for Facor V and Factor II

FDA 510(k) K093129 · Illumina, Inc.

Substantially Equivalent

510(k) numberK093129

Submission

Device name
Illumina Verncode Genotyping Test for Facor V and Factor II
Applicant
Illumina, Inc.
San Diego, CA, US
Received
October 2, 2009
Decision date
April 28, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NPQ – Test, Factor V Leiden Mutations, Genomic Dna Pcr
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7280
Specialty
Hematology

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 510(k)s with product code NPQ

510(k)DeviceApplicantDecision
K100980Invader Factor VNPQ · Traditional Hologic, Inc.06/01/2011SE
K093974Esenor Fii-Fv-Mthfr Genotyping Test, Esenor Fii-Fv Genotyping Test, Esenor Fii GenotypingNPQ · Traditional Osmetech Molecular Diagnostics04/22/2010SE
K082118Xpert Hemosil Factor II & Factor V AssayNPQ · Traditional Cepheid09/18/2009SE
K060564Infiniti SystemNPQ · Traditional AutoGenomics, Inc.02/07/2007SE

More from AutoGenomics, Inc.

510(k)DeviceDecision
K132750Illumina Miseqdx Cystic Fibrosis Clinical Sequencing AssayPFS · Traditional 11/19/2013SE
K124006Illumina Miseqdx Cystic Fibrosis 139-VARIANT AssayPFR · Traditional 11/19/2013SE
K093128Illumina Beadxpress SystemNSU · Traditional 04/28/2010SE

Questions and answers

When was Illumina Verncode Genotyping Test for Facor V and Factor II cleared by the FDA?

Illumina Verncode Genotyping Test for Facor V and Factor II (K093129) received a 510(k) decision of Substantially Equivalent on April 28, 2010, 208 days after the submission was received.

What is the product code of K093129?

The FDA product code is NPQ – Test, Factor V Leiden Mutations, Genomic Dna Pcr, a Class II (moderate risk) device regulated under 21 CFR 864.7280.