Get the free 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System - accessdata fda
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This document provides a summary of the 510(k) safety and effectiveness information regarding the eSensor® Warfarin Sensitivity Test and XT-8 System. It includes device descriptions, intended uses,
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How to fill out 510k summary for esensor
How to fill out 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System
01
Gather all necessary information about the eSensor® Warfarin Sensitivity Test and XT-8 System.
02
Include a description of the device, its intended use, and the patients it serves.
03
Detail the technological characteristics of the device and any materials used.
04
Provide information on performance testing, including any clinical studies or data supporting the device's efficacy.
05
Compare the device to a legally marketed predicate device to establish substantial equivalence.
06
Include labeling information, including instructions for use and any promotional materials.
07
Submit the completed 510(k) Summary to the FDA, ensuring all formatting and documentation guidelines are followed.
Who needs 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System?
01
Manufacturers of the eSensor® Warfarin Sensitivity Test and XT-8 System must prepare the 510(k) Summary.
02
Healthcare professionals and organizations aiming to use or distribute the device require the 510(k) Summary for regulatory compliance.
03
Regulatory agencies need the 510(k) Summary to evaluate and approve the device for safe market entry.
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People Also Ask about
What does high warfarin sensitivity mean?
If people with warfarin sensitivity take the average dose (or more) of warfarin, they are at risk of an overdose, which can cause abnormal bleeding in the brain, gastrointestinal tract, or other tissues, and may lead to serious health problems or death.
What happens if warfarin levels are too high?
Symptoms of overdose may include the following: bloody or red, or tarry movements. spitting or coughing up blood. heavy bleeding with your menstrual period. pink, red, or dark brown . coughing up or vomiting material that looks like coffee grounds. small, flat, round red spots under the skin.
What are the red flags for warfarin?
If bleeding risk is high* or INR >4.5, consider Vitamin K1 1–2 mg orally or 0.5–1 mg IV. Lower or omit the next dose of warfarin. Resume therapy at a lower warfarin dose when the INR approaches therapeutic range. Cease warfarin therapy; consider reasons for elevated INR and patient-specific factors.
What is warfarin sensitivity test?
Warfarin sensitivity testing will identify the CYP2C9 and VKORC1 genetic variants (i.e., genotype) present for the person tested. The results must be interpreted carefully to help determine if the person is likely to need a relatively lower or higher dose of warfarin. These results are interpreted by a specialist.
Why is warfarin high alert?
Talk to your healthcare team if you take warfarin and have these symptoms: Bleeding from a cut or the nose or gums that lasts less than 5 minutes. For example, if your gums bleed after brushing your teeth. Bleeding between menstrual periods. Diarrhea, vomiting or inability to eat for more than 24 hours. Fever.
What is a warfarin sensitivity test?
Anticoagulant therapies such as heparin and warfarin are considered high-alert medications, due to the high potential for patient harm if used improperly.
What are the symptoms of high warfarin?
Warfarin sensitivity testing will identify the CYP2C9 and VKORC1 genetic variants (i.e., genotype) present for the person tested. The results must be interpreted carefully to help determine if the person is likely to need a relatively lower or higher dose of warfarin. These results are interpreted by a specialist.
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What is 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System?
The 510(k) Summary for the eSensor® Warfarin Sensitivity Test and XT-8 System is a premarket submission made to the FDA demonstrating that the device is safe and effective, and substantially equivalent to a legally marketed device.
Who is required to file 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System?
Manufacturers or developers of the eSensor® Warfarin Sensitivity Test and XT-8 System are required to file a 510(k) Summary with the FDA.
How to fill out 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System?
To fill out the 510(k) Summary, the manufacturer must provide detailed information about the device, including its intended use, description, technological characteristics, performance data, labeling, and any substantial equivalence claims.
What is the purpose of 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System?
The purpose of the 510(k) Summary is to demonstrate to the FDA that the eSensor® Warfarin Sensitivity Test and XT-8 System is safe and effective for its intended use and to establish its equivalence to existing marketed devices.
What information must be reported on 510(k) Summary for eSensor® Warfarin Sensitivity Test and XT-8 System?
The information that must be reported includes device name, intended use, description of the technology, comparison to predicate devices, labeling information, and any clinical or non-clinical data supporting the device's safety and effectiveness.
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