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eq-prc lc warfarin genotyping kit
Trimgen
Summary: The eq-prc lc warfarin genotyping kit by Trimgen is used to determine genetic variations affecting warfarin metabolism. It is primarily used by clinicians in pharmacogenomics to tailor anticoagulant therapy.
FDA Clearance Information
Pathway
510K
Number
K073071 ↗
Decision Date
February 6, 2009
Product Code
ODW
Device Class
Class 2
Evidence
0 studies
The eq-prc lc warfarin genotyping kit was cleared via the FDA 510k pathway on February 6, 2009. Manufactured by Trimgen, it is classified as a Class 2 device under product code ODW.
What It Is
The eq-prc lc warfarin genotyping kit is a diagnostic tool that identifies genetic polymorphisms in patients that affect their response to warfarin, a common anticoagulant. By analyzing specific genetic markers, the kit helps clinicians predict the optimal warfarin dosage for individual patients, minimizing the risk of adverse effects. This genotyping is crucial for personalized medicine, particularly in managing anticoagulation therapy.
Clinical Applications
This genotyping kit is commonly used in clinical settings where patients are prescribed warfarin, such as cardiology, hematology, and internal medicine. It is particularly useful in outpatient clinics and hospitals where anticoagulation management is critical. The kit aids in determining the appropriate warfarin dose for patients with conditions like atrial fibrillation, deep vein thrombosis, or mechanical heart valves.
Indications for Use
The FDA-cleared indications for this kit involve its use in identifying genetic variations that impact warfarin metabolism. It is intended for patients who require warfarin therapy, allowing for more precise and personalized dosing.
Practical Considerations
The kit is compatible with standard laboratory equipment used for genetic testing. Clinicians should ensure proper sample collection and handling to maintain test accuracy. Familiarity with interpreting genetic results is essential for integrating this data into patient care.
Frequently Asked Questions
What is eq-prc lc warfarin genotyping kit used for?
It is used to identify genetic variations in patients that affect their response to warfarin, allowing for personalized dosing.
What specialties typically use this device?
Cardiology, hematology, and internal medicine specialists commonly use this device for managing anticoagulation therapy.
What are the FDA-cleared indications?
The kit is indicated for identifying genetic polymorphisms that influence warfarin metabolism, aiding in personalized anticoagulant therapy.
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.