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This document provides a comprehensive summary of the 510(k) premarket notification for the Xpert® C. difficile/Epi Assay, a qualitative in vitro diagnostic test for the rapid detection of Clostridium
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How to fill out Xpert® C. difficile/Epi 510(k) Summary
01
Obtain the Xpert® C. difficile/Epi 510(k) Summary document from the manufacturer or regulatory website.
02
Review the introduction section to understand the purpose and scope of the summary.
03
Fill in all required company information, including the name and address.
04
Provide details about the device, including its intended use and specifications.
05
Summarize the clinical performance data, including any studies conducted.
06
Include information on the safety and efficacy of the device.
07
Detail any potential risks associated with the use of the device.
08
Review the regulatory pathway and any applicable standards.
09
Provide a summary of the device’s technological characteristics compared to predicate devices.
10
Conclude with any additional comments or disclaimers as needed.
Who needs Xpert® C. difficile/Epi 510(k) Summary?
01
Healthcare professionals involved in diagnosing Clostridium difficile infections.
02
Laboratories performing testing for C. difficile and its strains.
03
Regulatory bodies assessing the safety and efficacy of medical devices.
04
Infection control personnel in hospitals and clinics.
05
Researchers in the field of infectious diseases.
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People Also Ask about
What is C difficile DNA amplification assay?
Clostridium difficile PCR is designed to amplify 2 different genes that are specific to toxigenic strains of C difficile: tcdB, which encodes for toxin B, and tcdC, which encodes for a toxin regulatory pathway.
What is the detection of C difficile?
Stool tests If C. difficile infection is suspected, one or more tests of a stool sample can show either the toxins or strains of the bacteria that produce toxins.
What is C diff epi?
C. difficile/Epi Assay is a qualitative in vitro diagnostic test. for rapid detection of toxin B gene sequences and for presumptive identification of 027/NAP1/BI strains of toxigenic Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having C.
What does positive C. diff PCR mean?
If your test shows that you have the C. diff toxin gene detected by PCR (polymerase chain reaction) - your sample is PCR positive, toxin negative. This means you have C. diff in your but do not have a C. diff infection.
What does C difficile PCR test for?
C. diff testing is most often used to find out if C. diff is causing diarrhea. But diarrhea can have many causes, so the test may be used with tests for parasites and other bacteria that also cause diarrhea.
What happens if you test positive for C. diff?
* What does a GDH positive result mean for me? GDH is an abbreviation for Glutamate dehydrogenase, which is a chemical found in C. diff. If the result is GDH positive a second test is performed to look for toxins that are produced when C. diff is causing an infection.
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What is Xpert® C. difficile/Epi 510(k) Summary?
The Xpert® C. difficile/Epi 510(k) Summary is a document that outlines the safety and effectiveness of the Xpert® C. difficile test, which is used for the detection of Clostridioides difficile infections (CDI) and epidemic strains.
Who is required to file Xpert® C. difficile/Epi 510(k) Summary?
Manufacturers of the Xpert® C. difficile test or any related diagnostic devices are required to file the 510(k) Summary with the U.S. Food and Drug Administration (FDA).
How to fill out Xpert® C. difficile/Epi 510(k) Summary?
To fill out the Xpert® C. difficile/Epi 510(k) Summary, manufacturers must provide detailed information on the device's intended use, description, comparison to existing devices, data supporting the device's safety and effectiveness, and any relevant labeling information.
What is the purpose of Xpert® C. difficile/Epi 510(k) Summary?
The purpose of the Xpert® C. difficile/Epi 510(k) Summary is to demonstrate to the FDA that the diagnostic device is safe and effective for its intended use, thereby allowing it to be marketed in the United States.
What information must be reported on Xpert® C. difficile/Epi 510(k) Summary?
The information that must be reported includes the device's name, classification, intended use, device description, performance testing results, labeling, and any adverse event information related to the device.
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