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This document provides a summary of the 510(k) premarket notification for the VIDAS® CEA (S) Assay, detailing its classification, intended use, technology characteristics, and performance data to
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How to fill out 510k summary vidas cea
How to fill out 510(k) SUMMARY VIDAS® CEA (S) Assay
01
Gather all necessary information about the VIDAS® CEA (S) Assay.
02
Identify the intended use of the assay and ensure it complies with FDA requirements.
03
Collect performance data, including clinical studies and analytical validation results.
04
Prepare a summary of the device labeling and its instructions for use.
05
Compile information regarding the predicate device for comparison.
06
Organize all documents and data in accordance with the FDA's guidance for 510(k) submissions.
07
Complete the 510(k) cover sheet and include it with the submission.
08
Review and ensure all sections of the summary are complete and accurate.
09
Submit the 510(k) summary electronically through the FDA submission portal.
Who needs 510(k) SUMMARY VIDAS® CEA (S) Assay?
01
Manufacturers planning to market the VIDAS® CEA (S) Assay in the United States.
02
Clinical laboratories that wish to utilize the assay for cancer diagnostics.
03
Healthcare providers needing verification of the assay’s clearance for clinical use.
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People Also Ask about
What is the reference value for CEA?
The reference range is 0-2.9 ng/mL of blood. Generally, healthcare providers consider typical CEA levels to be between 0 and 2.9 ng/mL.
What level of CEA indicates cancer?
Patients with AAA often have a co-existing aneurysm of the CIA. Normal CIA diameter ranges from 9.7 mm to 12.3 mm. 4, 5 Definitions of size for a CIA aneurysm are variable; suggestions range from 15 mm to 20 mm to 24 mm. 6, 7, 8 Similarly, the size recommended for CIA aneurysm repair ranges between 30 mm and 40 mm.
What is the normal range for CEA biomarker?
The normal range for CEA is 0 to 2.5 nanograms per milliliter of blood (ng/mL). If CEA levels remain elevated during treatment, the treatment may not have been as successful as hoped. Anything greater than 10 ng/mL suggests extensive disease, and levels greater than 20 ng/mL suggest the cancer may be spreading.
What is CEA test in English?
What is a CEA test? CEA stands for carcinoembryonic antigen. CEA is a protein that is a type of "tumor marker." Tumor markers are substances that are often made by cancer cells or by normal cells in response to cancer. High levels of CEA are normal in healthy, unborn babies.
What is normal CEA measurement?
The normal levels of CEA in blood should range between 0 and 2.5 µg/ml. Those who smoke have higher CEA levels. This is why doctors suggest avoiding smoking for a few days before taking a blood sample. However, the carcinoembryonic antigen test is not a screening test for cancer diseases.
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What is 510(k) SUMMARY VIDAS® CEA (S) Assay?
The 510(k) SUMMARY VIDAS® CEA (S) Assay is a regulatory submission to the FDA that demonstrates that the VIDAS® CEA (S) assay is safe and effective for measuring carcinoembryonic antigen (CEA) levels in serum or plasma for cancer diagnosis and management.
Who is required to file 510(k) SUMMARY VIDAS® CEA (S) Assay?
Manufacturers of the VIDAS® CEA (S) assay or other entities that significantly modify or introduce a new version of the assay are required to file a 510(k) summary to obtain FDA clearance.
How to fill out 510(k) SUMMARY VIDAS® CEA (S) Assay?
To fill out the 510(k) summary for the VIDAS® CEA (S) assay, manufacturers must provide information including device description, intended use, technological comparison, performance data, labeling, and biocompatibility information as outlined in FDA guidelines.
What is the purpose of 510(k) SUMMARY VIDAS® CEA (S) Assay?
The purpose of the 510(k) summary for the VIDAS® CEA (S) assay is to demonstrate to the FDA that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness.
What information must be reported on 510(k) SUMMARY VIDAS® CEA (S) Assay?
The information that must be reported includes device identification, intended use, technological characteristics, performance testing results, labeling, and any other relevant information to establish substantial equivalence.
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