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The kit is for quantitating retinol binding protein in human urine as an aid in diagnosing kidney disease.

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This is a 510(k) clearance letter for a Retinol Binding Protein (RBP) RID Kit, which is an in vitro diagnostic device. The provided documents do not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The letter is a regulatory document from the FDA stating that the device, Human Retinol Binding Protein RID Kit for Urine Measurement, is substantially equivalent to legally marketed predicate devices for quantitating retinol binding protein in human urine as an aid in diagnosing kidney disease.

Therefore, I cannot provide the requested information for the following sections:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
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

These details would typically be found in the 510(k) submission itself or in a separate clinical study report, which is not included in the provided text. The FDA clearance process for this type of device (Class I in vitro diagnostic) primarily focuses on demonstrating substantial equivalence to a predicate device rather than requiring extensive de novo clinical trials with predefined performance criteria as might be the case for higher-risk devices or novel technologies.

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