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This document contains the summary of a 510(k) premarket notification for the VIDAS® AFP Assay, detailing the device's intended use, technological characteristics, and performance data for measuring
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How to fill out 5 10k summary vidasafpassay
How to fill out 5 10(k) SUMMARY VIDAS®AFP'Assay
01
Begin by gathering all necessary patient information and sample data.
02
Ensure that the VIDAS®AFP assay kit is at room temperature and that all reagents are available.
03
Prepare the samples according to the protocol, ensuring proper dilution if required.
04
Load the samples into the VIDAS® instrument along with controls as per device guidelines.
05
Select the appropriate settings on the VIDAS® instrument to run the AFP assay.
06
Start the assay and monitor the progress using the instrument interface.
07
Once the test is complete, retrieve the results and review them for accuracy.
08
Document the findings in the patient's medical record and discuss the results with the clinician.
Who needs 5 10(k) SUMMARY VIDAS®AFP'Assay?
01
Individuals undergoing evaluation for liver cancer or other hepatic conditions.
02
Healthcare professionals involved in diagnosis and monitoring of hepatocellular carcinoma.
03
Patients at risk for elevated alpha-fetoprotein levels, such as those with chronic hepatitis or cirrhosis.
04
Clinics and laboratories that provide diagnostic testing for oncology and liver diseases.
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People Also Ask about
How do you read AFP test results?
AFP levels in men and women who are not pregnant vary for age and race. Generally, an AFP level between 0 ng/mL to 10 ng/ml or even up to 40 ng/mL can be normal for adults. In pregnant women, AFP levels increase from about the 14th week of pregnancy until about 32 weeks.
What AFP levels indicate Down syndrome?
The median maternal serum alphafetoprotein (AFP) level at 14-20 weeks' gestation in 61 pregnancies associated with Down syndrome was 0·72 multiples of the median (MoM) value for a series of 36 652 singleton pregnancies unaffected by Down syndrome or neural-tube defect—a statistically significant reduction.
What level of AFP indicates spina bifida?
levels above 2-5 times the normal median at 16-18 weeks of gestation will have an approximately 1-in-20 chance of having a fetus with open spina bifida; the risk of having any N.T.D. will be approximately 1 in 10.
How to interpret AFP results?
Alpha fetoprotein (AFP) is a protein produced by the liver and yolk sac of a fetus. AFP has no normal function in adults. The alpha fetoprotein test (AFP) is a blood test performed to measure, diagnose, or monitor fetal distress or fetal abnormalities. It can also detect some liver disorders and some cancers in adults.
What is a concerning AFP level?
AFP is measured in nanograms per milliliter (ng/mL), with normal levels less than 20 ng/mL. Levels above 400 ng/mL may indicate a liver tumor or other cancer.
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What is 5 10(k) SUMMARY VIDAS®AFP'Assay?
The 5 10(k) SUMMARY VIDAS®AFP'Assay is a regulatory submission to the FDA that demonstrates that this diagnostic test for alpha-fetoprotein (AFP) is safe and effective for its intended use.
Who is required to file 5 10(k) SUMMARY VIDAS®AFP'Assay?
Manufacturers of medical devices, including diagnostic tests such as the VIDAS®AFP'Assay, must file a 5 10(k) summary to obtain clearance from the FDA before marketing their product.
How to fill out 5 10(k) SUMMARY VIDAS®AFP'Assay?
To fill out a 5 10(k) summary, manufacturers need to provide information including device description, intended use, substantial equivalence to a predicate device, performance data, labeling, and quality control measures.
What is the purpose of 5 10(k) SUMMARY VIDAS®AFP'Assay?
The purpose of the 5 10(k) SUMMARY VIDAS®AFP'Assay is to obtain FDA clearance to market the device by demonstrating it is as safe and effective as a previously approved device.
What information must be reported on 5 10(k) SUMMARY VIDAS®AFP'Assay?
The information that must be reported includes device description, indications for use, comparisons to predicate devices, performance testing results, and details about manufacturing processes and quality assurance.
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