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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE. 510(k) Number:
k103037
B. Purpose for Submission:
New device
C. Measured:
Urinary nitrite and leukocyte esterase
D.
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How to fill out urinary nitrite and leukocyte
01
To fill out urinary nitrite and leukocyte, follow these steps:
02
Start by collecting a fresh urine sample in a clean container.
03
Make sure to wash your hands before handling the sample to prevent contamination.
04
Take a urinary nitrite test strip and dip it into the urine sample for a few seconds.
05
Remove the strip and shake off any excess urine.
06
Wait for the indicated time (usually a few minutes) for the test results to appear.
07
Compare the color change on the test strip with the provided color chart to interpret the results for urinary nitrite levels.
08
Repeat steps 3-6 for the leukocyte test strip to determine leukocyte levels.
09
Record the results for both tests accurately.
10
Dispose of the used test strips and urine sample properly.
11
Note: It is always recommended to refer to the specific instructions provided with the test kit for more precise guidance.
Who needs urinary nitrite and leukocyte?
01
Urinary nitrite and leukocyte tests are useful for individuals who suspect urinary tract infections (UTIs) or want to monitor their urinary health.
02
Common individuals who may need these tests include:
03
- Those experiencing symptoms of a UTI such as frequent urination, burning sensation during urination, cloudy or foul-smelling urine, or lower abdominal pain.
04
- People with a history of recurrent UTIs.
05
- Individuals with certain medical conditions that make them more prone to UTIs, such as diabetes or kidney stones.
06
- Those undergoing treatment for a UTI to monitor the effectiveness of the prescribed medication.
07
It is important to consult a healthcare professional for proper evaluation and guidance regarding urinary nitrite and leukocyte testing.
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What is urinary nitrite and leukocyte?
Urinary nitrite is a chemical produced by bacteria, and leukocytes are white blood cells that indicate inflammation or infection in the body.
Who is required to file urinary nitrite and leukocyte?
Individuals with suspected urinary tract infections or other related health conditions may be required to submit a urine sample for testing urinary nitrite and leukocyte.
How to fill out urinary nitrite and leukocyte?
To fill out a urinary nitrite and leukocyte test, a urine sample is collected in a sterile container provided by a healthcare provider and submitted for laboratory analysis.
What is the purpose of urinary nitrite and leukocyte?
The purpose of testing urinary nitrite and leukocyte is to diagnose or monitor urinary tract infections, kidney disease, or other medical conditions affecting the urinary system.
What information must be reported on urinary nitrite and leukocyte?
The laboratory report for urinary nitrite and leukocyte testing typically includes the levels of nitrite, leukocytes, and other relevant substances found in the urine sample.
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