(140 days)
The Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is nonabsorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is measured using a bichromatic (293, 700nm) end-point technique.
Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients receiving cytotoxic drugs.
This application sheet has been developed for the Dade Dimension Clinical Chemistry Analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.
The Randox Laboratories Limited Uric Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of uric acid in serum. The method used is based on UV detection. Uric acid, which absorbs light at 293nm, is converted by uricase to allantoin, which is nonabsorbing at 293nm. The change in absorbance at 293nm due to the disappearance of uric acid is indirectly proportional to the concentration of uric acid in the sample and is measured using a bichromatic (293, 700nm) end-point technique.
The input provided describes an FDA 510(k) clearance letter and an "Indications For Use" statement for a device named "URIC ACID" from Randox Laboratories Ltd. This document does not contain information about acceptance criteria, study design, or performance metrics in a way that allows for the creation of the requested table and detailed study description about device performance against acceptance criteria.
The document is a regulatory clearance for a diagnostic test kit (an in vitro diagnostic reagent) for the quantitative determination of uric acid in serum. It outlines the method used (UV detection based on uricase converting uric acid to allantoin) and the clinical utility of uric acid measurements.
Therefore, I cannot provide the requested information because the provided text does not contain the details about acceptance criteria or a study that proves the device meets those criteria.
Specifically, the document lacks:
- Acceptance criteria values and reported device performance values: It describes what the device does (measures uric acid) but not how well it performs against specific benchmarks (e.g., accuracy, precision, linearity ranges, acceptable bias).
- Sample size and data provenance for a test set: No figures or origin of data are mentioned.
- Number and qualifications of experts for ground truth: Not applicable for a chemical assay.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable, as this is a chemical assay, not an AI-assisted diagnostic tool for human readers.
- Standalone performance: While the document implies standalone performance (the kit itself measures uric acid), it doesn't quantify this performance.
- Type of ground truth: For a chemical assay, the "ground truth" would typically be a reference method or known concentration standards, but these are not described.
- Training set sample size: Not applicable to this type of chemical assay.
- How ground truth for the training set was established: Not applicable.
The document is a regulatory approval, not a scientific study report detailing performance metrics.
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.