📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- For in vitro genotyping of genetic variants associated with warfarin sensitivity or metabolism.
- For use with patients being considered for or receiving warfarin therapy, as an aid in evaluating warfarin dose requirements.
- For use by qualified laboratories according to the device labeling and validated laboratory procedures.
Clinical Applications
- Genetic testing as part of the initial evaluation of a patient who may start warfarin.
- Supporting individualized warfarin dose selection in patients requiring anticoagulation.
- Evaluating genetic factors that may contribute to unusually high or low warfarin dose requirements.
- Using pharmacogenetic results together with INR values, age, diet, interacting medications, liver function and other clinical factors.
Practical Considerations
- This is a laboratory genotyping assay, not an implanted device or an intravascular device; MRI safety and device sizing do not apply.
- The test requires an appropriately collected patient specimen and compatible laboratory equipment and procedures.
- Genotyping results should not be used alone to select or adjust warfarin doses.
- Patients still require clinical monitoring, including INR testing, after warfarin is started or adjusted.
- The FDA clearance was granted through the 510(k) pathway in 2009; laboratories should confirm current labeling, availability and applicable regulatory requirements before use.
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.