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This reaqent is for the quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma by measurement of the initial rate of reaction.

This urea nitrogen test system is a device intended to measure urea nitrogen (an endproduct of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Urea Nitrogen (BUN) test system

The provided document is a 510(k) clearance letter from the FDA for a Urea Nitrogen (BUN) test system. It does not contain information regarding detailed acceptance criteria, device performance studies, or specifics about a test set (like sample size, data provenance, expert consensus, etc.).

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document primarily states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. The specific performance data and study details requested are typically found in the 510(k) submission itself, not in the clearance letter.

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