Test, Factor V Leiden Mutations, Genomic Dna Pcr
The Factor V Leiden mutation genomic DNA PCR test is a hematology in vitro diagnostic device used to detect the Factor V Leiden mutation in genomic DNA, aiding in the evaluation of patients with suspected thrombophilia and increased risk of abnormal blood clotting. It is classified as FDA Class 2 under regulation 864.7280 in the Hematology specialty (reviewed by Pathology panel), requiring 510(k) clearance. Product code NPQ is not eligible for third-party review.
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Basic Information
- Product Code
- NPQ
- Device Class
- FDA class 2
- Regulation Number
- 864.7280
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K100980 | INVADER FACTOR V | Jun 01, 2011 | Substantially Equivalent | Hologic, Inc. |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | Apr 28, 2010 | Substantially Equivalent | Illumina, Inc. |
| K093974 | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING | Apr 22, 2010 | Substantially Equivalent | Osmetech Molecular Diagnostics |
| K082118 | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY | Sep 18, 2009 | Substantially Equivalent | Cepheid |
| K060564 | INFINITI SYSTEM | Feb 07, 2007 | Substantially Equivalent | AutoGenomics, Inc. |
| DEN030005 | FACTOR V LEIDEN KIT | Dec 17, 2003 | Unknown | Roche Diagnostics Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.