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New submission to add the Cobas u 411 Urine Analyzer for use with the Chemstrip 10 UA

New submission to add the Cobas u 411 Urine Analyzer for use with the Chemstrip 10 UA 2026

New submission to add the Cobas u 411 Urine Analyzer for use with the Chemstrip 10 UA Preview on Page 1

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The document is a 510(k) decision summary for the Cobas u 411 Urine Analyzer, submitted by Roche Diagnostics Corporation. It details the device's intended use for qualitative and semi-quantitative urinalysis using Chemstrip 10 UA test strips to measure various urine analytes. The summary includes regulatory information, device description, performance characteristics, and comparisons with a predicate device, demonstrating substantial equivalence. The analyzer is designed for prescription in vitro diagnostic use and employs reflectance photometry technology.

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How to use or fill out New submission to add the Cobas u 411 Urine Analyzer for use with the Chemstrip 10 UA

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Click ‘Get Form’ to open it in the editor.
Begin by filling in the '510(k) Number' field with 'k093555'. This is essential for tracking your submission.
In the 'Purpose for Submission' section, clearly state 'New submission to add the Cobas u 411 Urine Analyzer for use with the Chemstrip 10 UA test strip k896454'.
Complete the 'Measurand' section by listing all relevant analytes such as urine pH, leukocytes, nitrite, and others as specified.
Fill out the 'Intended Use' section, ensuring you include that this device is intended for prescription in vitro diagnostic use only.
Review all sections carefully before submitting. Ensure that all fields are filled accurately to avoid delays.

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Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What does a Chemstrip 10 MD test strip measure?

The Chemstrip 10 MD test strip is a multi-parameter urinalysis test strip, which measures specific gravity, pH, ketone, leukocytes, blood/hemoglobin, nitrite, protein, urobilinogen, bilirubin and glucose in the .

What is the principle of analysis?

Its principle is diazotation of sulfanilic acid with nitrites, originating in by bacterial reduction of nitrates, producing a diazonium salt. Azo-coupling follows that yielding a pink or even violet color (Fig. 2).

What is the working principle of analyzer?

The analysers working principle involves the use of test strips impregnated with specific chemical reagents. The analyser, usually controlled by a microcomputer, uses optical sensors to detect colour changes on these reagent strips once they react with components.

What is the principle of Sysmex analyzer?

Measurement principles: Each test strip is scanned with a colour CMOS sensor and photometry is performed. Automatically detect the position of the test strip pads. By improving the light path, cloudiness and specific gravity became less affected by turbidity.

What is the principle of refractometer?

The refractive index correlates with increasing solids within a sample; as light waves pass through the solution, the light is bent depending on the amount of solute within the sample. As light is bent through a prism, the optical density is measured on a scale designed for gravity.

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What is the principle of a Sysmex analyzer?

Principles of measurement Blood is sampled and diluted, and moves through a tube thin enough that cells pass by one at a time. Characteristics about the cell are measured using lasers (fluorescence flow cytometry) or electrical impedance.

How to use a analyzer machine?

0:04 2:12 Next dip the strip in distilled. Water tap it on a paper towel and place it on the strip.MoreNext dip the strip in distilled. Water tap it on a paper towel and place it on the strip. Holder. Results will display in 60 to 90 seconds.

What is cobas test?

The cobas u 601 analyzer is a fully automated urinalysis system intended for the in vitro quantitative, qualitative or semi-quantitative determination of analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and erythrocytes, as well as specific gravity, color,

New submission to add the Cobas u 411 Urine Analyzer for use with the Chemstrip 10 UA 2026

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