(25 days)
For the quantitative determination of urea in serum. For IN VITRO diagnostic use.
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
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This document is a 510(k) clearance letter from the FDA for a diagnostic device called "Urea-L3K Assay." It states that the device is substantially equivalent to a legally marketed predicate device.
The letter itself does not contain details about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment. These are typically found in the 510(k) submission document itself, which is not provided here.
Therefore,Based on the provided document, the following information is not available:
- A table of acceptance criteria and the reported device performance: This document only states that the device is "substantially equivalent" to a predicate device, but does not provide specific performance metrics or acceptance criteria it met.
- Sample size used for the test set and the data provenance: No information is given about the test set size or its origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
- Adjudication method for the test set: No details on adjudication are provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a diagnostic assay (chemical test), not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not applicable, and no information about it is present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is an assay, not an algorithm, this question is not applicable.
- The type of ground truth used: The document does not specify how ground truth was established for the studies supporting the submission. In the context of an assay for urea, the ground truth would typically be established by a reference method or validated primary method for measuring urea.
- The sample size for the training set: No information regarding a training set size is provided. This is a chemical assay, not typically an AI/ML model that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable, as detailed above.
The only relevant information directly from the document is related to the device and its intended use:
- Device Name: Urea-L3K Assay
- Regulatory Class: II
- Product Code: CDQ
- Indications for Use: For the quantitative determination of urea in serum. For IN VITRO diagnostic use.
- Purpose of measurement: "Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases."
To obtain the detailed information requested, one would need to review the original 510(k) submission (K993178) filed by Diagnostics Chemicals Limited.
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.