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This document provides a summary of the 510(k) premarket notification submission for the Tina-quant Albumin Gen. 2 assay, detailing the device, its intended use, and substantial equivalence to other
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How to fill out tina-quant albumin gen 2

How to fill out Tina-quant Albumin Gen. 2 Assay
01
Ensure all materials are at room temperature.
02
Obtain a blood sample from the patient and prepare serum or plasma.
03
Use a calibrated pipette to measure the required volume of the sample.
04
Add the sample to the designated reagent in the assay plate according to the manufacturer's instructions.
05
Incubate the mixture at the recommended temperature for the specified time period.
06
Use a spectrophotometer to measure the absorbance at the appropriate wavelength.
07
Calculate the concentration of albumin in the sample using the provided calibration curve.
Who needs Tina-quant Albumin Gen. 2 Assay?
01
Patients with suspected kidney disease.
02
Individuals undergoing routine health check-ups.
03
Diabetics monitoring their kidney function.
04
Patients with conditions that could impact protein levels, such as liver disease.
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People Also Ask about
Should I worry about albumin in ?
A normal amount of albumin in your is less than 30 mg/g. Anything above 30 mg/g may mean you have kidney disease, even if your estimated glomerular filtration (eGFR) number is above 60.
What causes a positive albumin level?
Higher than normal albumin levels in your blood may be a sign of dehydration, which may be caused by severe diarrhea or other conditions. If your albumin levels are not in the normal range, it doesn't always mean you have a medical condition that needs treatment.
What is albumin positive in a test?
Interpretation of results ACRNormal mg/mmol level Male – less than or equal to 2.5. Female- less than or equivalent to 3.5. Interpretation No kidney disease unless other tests show there is. Referral to a kidney specialist is recommended when the ACR is greater than or equal to 30 mg/mmol. Sep 14, 2024
What is the most common cause of albumin in the ?
Albuminuria (proteinuria) is caused by kidney damage, specifically when the damage occurs in the glomerulus (the kidney's filter). Sometimes this is temporary (short-term damage), while other times it is chronic (long-term damage).
What is albumin creatinine ratio reading?
An albumin blood test measures the amount of albumin in your blood. Albumin is a protein made by your liver. Low albumin levels can be a sign of liver or kidney disease or another medical condition. High levels may be a sign of dehydration.
What is a normal albumin level in ?
Albuminuria is a sign of kidney disease and means that you have too much albumin in your . Albumin is a protein found in the blood. A healthy kidney doesn't let albumin pass from the blood into the . A damaged kidney lets some albumin pass into the . The less albumin in your , the better.
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What is Tina-quant Albumin Gen. 2 Assay?
The Tina-quant Albumin Gen. 2 Assay is a laboratory test used to measure the concentration of albumin in serum or plasma samples. It is commonly used for evaluating kidney function and for diagnosing and monitoring various medical conditions.
Who is required to file Tina-quant Albumin Gen. 2 Assay?
Healthcare providers and laboratories that conduct tests to measure albumin levels are required to file the Tina-quant Albumin Gen. 2 Assay to ensure accurate monitoring of patients' health, especially those with conditions such as diabetes or kidney disease.
How to fill out Tina-quant Albumin Gen. 2 Assay?
To fill out the Tina-quant Albumin Gen. 2 Assay, healthcare professionals should collect a serum or plasma sample, properly label it with patient information, and follow the laboratory's protocol for submission, including any required documentation and specific instructions for the assay.
What is the purpose of Tina-quant Albumin Gen. 2 Assay?
The purpose of the Tina-quant Albumin Gen. 2 Assay is to quantify albumin levels, which helps in diagnosing kidney disorders, monitoring patients at risk of kidney disease, and assessing proteinuria, which can indicate underlying health issues.
What information must be reported on Tina-quant Albumin Gen. 2 Assay?
The information that must be reported includes the patient's albumin concentration in mg/dL or g/L, the reference range for normal values, the test date, patient's identification details, and any relevant clinical information provided by the healthcare provider.
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