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infiniti 2c9 vkorc1 multiplex assay for warfarin
Autogenomics
Summary: The Infiniti 2C9 VKORC1 Multiplex Assay is a diagnostic tool used to determine genetic variations affecting warfarin metabolism. It is primarily used by clinicians in settings where warfarin therapy is managed, such as cardiology and hematology.
FDA Clearance Information
Pathway
510K
Number
K073014 ↗
Decision Date
January 23, 2008
Product Code
ODW
Device Class
Class 2
Evidence
0 studies
The Infiniti 2C9 VKORC1 Multiplex Assay by Autogenomics was cleared via the FDA 510(k) pathway on January 23, 2008. It is classified as a Class 2 device under product code ODW.
What It Is
The Infiniti 2C9 VKORC1 Multiplex Assay is a genetic test designed to identify polymorphisms in the CYP2C9 and VKORC1 genes. These genes influence the metabolism and sensitivity to warfarin, a common anticoagulant. By analyzing these genetic markers, the assay helps clinicians personalize warfarin dosing to improve therapeutic outcomes and reduce the risk of adverse effects.
Clinical Applications
This assay is commonly used in cardiology and hematology clinics where patients are prescribed warfarin for conditions such as atrial fibrillation, deep vein thrombosis, or pulmonary embolism. It is particularly useful in settings where personalized medicine is emphasized, allowing for tailored dosing strategies based on genetic makeup. The test is typically performed in outpatient settings or specialized laboratories.
Indications for Use
The FDA indications for this assay involve its use in identifying genetic variations that affect warfarin metabolism. It is intended for patients who are prescribed warfarin and require personalized dosing to optimize treatment efficacy and safety.
Practical Considerations
The assay requires a blood sample, and results are typically available within a few days. It is compatible with standard laboratory equipment used for genetic testing. Clinicians should consider the patient's overall clinical picture and other medications when interpreting results.
Frequently Asked Questions
What is Infiniti 2C9 VKORC1 Multiplex Assay used for?
It is used to identify genetic variations that affect how a patient metabolizes warfarin, aiding in personalized dosing.
What specialties typically use this device?
Cardiology and hematology specialists frequently use this assay in managing patients on warfarin therapy.
What are the FDA-cleared indications?
The assay is indicated for identifying genetic markers that influence warfarin metabolism to guide dosing decisions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.