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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:

1. 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).
2. Sample size and data provenance for a test set: No figures or origin of data are mentioned.
3. Number and qualifications of experts for ground truth: Not applicable for a chemical assay.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is a chemical assay, not an AI-assisted diagnostic tool for human readers.
6. Standalone performance: While the document implies standalone performance (the kit itself measures uric acid), it doesn't quantify this performance.
7. 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.
8. Training set sample size: Not applicable to this type of chemical assay.
9. 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.

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The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum, plasma or urine on both automated and manual systems.

The Sigma Diagnostics INFINJTY™ Uric Acid Reagent is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by the 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.

This reagent is based upon the methods of Trivedi and Kabasakalland with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).

The series of reactions involved in the assay system is as follows:

• Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1 .
  Uric Acid + O2 + H2O _ Uricase _ Allantoin + CO2 + H2O2

• The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
  HoOs + 4-AAP + TBHB Peroxidase \ Ouinoneimine + H2O

Here's a breakdown of the acceptance criteria and study information for the Sigma Diagnostics INFINITY™ Uric Acid Reagent, Procedure 684, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For an in vitro diagnostic (IVD) like this, specific analytical performance characteristics (e.g., precision, accuracy, linearity, lower limit of detection, upper limit of quantitation, interference) would typically be detailed in the full 510(k) submission but are not explicitly presented as acceptance criteria or reported performance values in this summary. The submitted information focuses on substantial equivalence to a predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 126 samples were used for the correlation study.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. Given the nature of a correlation study comparing a new reagent to an existing one, it's generally conducted prospectively using fresh or banked clinical samples. The use of "plasma samples" suggests human biological samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document.

For an IVD like a uric acid reagent, the "ground truth" for the test set is established by the reference method (the predicate device, in this case, Sigma Diagnostics Uric Acid Reagent, Procedure No. 685). The accuracy of the predicate device is assumed based on its prior clearance and validation. Clinical experts are not typically involved in establishing the "ground truth" for individual quantitative measurements in such a direct comparison study; instead, the existing, validated method serves as the comparator.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document.

Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretations (e.g., image-based diagnosis) where multiple human readers assess cases and a consensus or tie-breaking mechanism is needed to establish ground truth. For a quantitative chemical assay, the comparison is directly between the numerical results of two different analytical methods.

5. 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 information is not applicable and not provided in the document.

MRMC studies and the concept of "human readers improving with AI assistance" pertain to artificial intelligence (AI) systems designed to aid human interpretation, particularly in image analysis. This document describes a chemical reagent for quantitative laboratory measurement, not an AI-assisted diagnostic tool for subjective human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided in the document, as it describes a chemical reagent, not a software algorithm. The "device performance" refers to the analytical performance of the reagent system.

7. The Type of Ground Truth Used

The "ground truth" for the correlation study was the measurement of uric acid levels obtained by the predicate device, Sigma Diagnostics Uric Acid Reagent, Procedure No. 685 (K853357). This can be considered a form of reference method comparison or comparative measurement data.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document.

Chemical reagents like this do not typically have "training sets" in the sense of machine learning algorithms. Their performance characteristics are established through analytical validation studies (e.g., linearity, precision, accuracy, interference studies) and then compared to a predicate using clinical samples (the "test set" in this context). The formulation and optimization of the reagent itself would involve R&D, but not a "training set" of data in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided in the document for the reasons stated in point 8.

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The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum or urine on both automated and manual systems.

The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the 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.

This reagent is based upon the methods of Trivedi and Kabasakallan with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).

The series of reactions involved in the assay system is as follows:

• Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1.
  Uric Acid + O2 + H2O Uricase > Allantoin + CO2 + H2O2

• The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
  H2O2 + 4-AAP + TBHB Peroxidase > Quinoneimine + H2O

The Sigma Diagnostics INFINITY™ Uric Acid Reagent (Procedure No. 684) is a device intended for the in vitro quantitative determination of uric acid in human serum or urine. It is explicitly indicated for use in the diagnosis and treatment of numerous renal and metabolic disorders. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study report with acceptance criteria and performance data. Therefore, many of the requested elements for a detailed study report are not explicitly available in the provided text.

Based on the provided information, here's a breakdown of the available details:

Acceptance Criteria and Reported Device Performance

The 510(k) summary states that the INFINITY™ Uric Acid Reagent is "substantially equivalent to, and is the same product as the TRACE Scientific Uric Acid Reagent kit cleared by the FDA as K971485." This implies that the acceptance criteria for this 510(k) submission were met by demonstrating this substantial equivalence, often through comparison of analytical performance characteristics (e.g., precision, accuracy, linearity, measuring range) to the predicate device. However, the specific quantitative acceptance criteria and the reported performance against these criteria are not detailed in the provided summary.

Table of Acceptance Criteria and Reported Device Performance:

Study Details:

As this is a 510(k) summary, it focuses on substantial equivalence rather than a detailed standalone clinical study report. Therefore, specific details about sample sizes, ground truth establishment, or expert involvement for a de novo study are not present. The "study" here refers to the comparisons made to establish substantial equivalence with the predicate device (TRACE Scientific Uric Acid Reagent kit, K971485).

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text. This type of information would typically be in a more detailed study report, outlining the samples used for comparison studies against the predicate.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. For a diagnostic reagent, ground truth is typically established by reference methods or established laboratory standards, not by human expert interpretation in the same way it would be for an imaging AI device.

3. Adjudication method for the test set:

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in human expert interpretations, which is not relevant for a quantitative chemical reagent.

4. 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:

   • No. This is a chemical reagent, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, MRMC studies are not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. A chemical reagent operates as a "standalone" analytical system, producing a quantitative result without human interpretive input beyond sample handling and instrument operation. The substantial equivalence demonstration would have evaluated the performance of the reagent directly.

6. The type of ground truth used:

   • For a chemical assay, the "ground truth" for demonstrating substantial equivalence typically involves comparison against:
     • Reference method/materials: Established analytical methods or certified reference materials with known uric acid concentrations.
     • Predicate device results: Direct comparison of results obtained with the new device versus the predicate device on the same set of patient samples.
   • The specific method used is not detailed in the provided text, but it would fall into one of these categories.

7. The sample size for the training set:

   • Not applicable/Not specified. Chemical reagents do not typically have "training sets" in the same sense as machine learning algorithms. Their formulation and optimization are based on chemical principles and experimental validation, not iterative training on data.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified, as there is no "training set" in the context of a chemical reagent.

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The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine. Measurements of uric acid 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.

Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to vield a quinoneimine dye. The resulting change in absorbance at 548 nm is proportional to the uric acid concentration in the sample.

The provided text describes a 510(k) submission for the Abbott Laboratories Uric Acid assay. This submission focuses on establishing substantial equivalence to a predicate device rather than a new technology proving clinical effectiveness. Therefore, the information typically requested for AI/ML devices regarding acceptance criteria, study design, and ground truth for clinical performance is not directly applicable or available in this document.

However, I can extract information related to the performance characteristics that were used to demonstrate substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate table, but it describes the performance characteristics that indicate substantial equivalence. The comparative performance is assessed against the Boehringer Mannheim® Uric Acid assay (K873363) on the Hitachi® 717 Analyzer.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size (number of patients or samples) used for the comparative performance studies. It states "Comparative performance studies were conducted" and "Precision studies were conducted using the Uric Acid assay" with "two levels of control material."

• Sample Size: Not specified.
• Data Provenance: Not specified. Based on the context of an in-vitro diagnostic device submission, the data would typically be from laboratory testing using human serum, plasma, or urine samples, likely collected retrospectively or prospectively for method validation purposes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable to this type of device and submission. The "ground truth" for a Uric Acid assay is the actual concentration of uric acid in a sample, typically determined by a reference method or the predicate device itself. Expert consensus is not a method for establishing the concentration of a chemical analyte.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., imaging devices) where multiple human readers assess a case and discrepancies need resolution. For a quantitative chemical assay, the comparison is directly between numerical results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a simple quantitative chemical assay.

6. Standalone (Algorithm Only) Performance:

Yes, the studies described are essentially a standalone performance assessment of the Abbott Uric Acid assay (the "algorithm" or measurement method in this context) compared to a predicate device. The performance characteristics reported (correlation, slope, intercept, precision, linearity, sensitivity) are all measures of the device's inherent analytical performance. There is no "human-in-the-loop" aspect to these measurements.

7. Type of Ground Truth Used:

The ground truth used for the comparative studies was the results obtained from the predicate device, the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer. For precision studies, the ground truth would be considered the true concentration of uric acid in the control materials.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a "training set" in the conventional sense. The device is a chemical assay, and its performance is based on the chemical reactions and optical measurement principles, not on a trained algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" for this type of device.

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The Uric Acid assay is used for the quantitation of uric acid in serum, plasma, or urine on the ALCYON 300/300i Analyzer. Measurements of uric acid 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.

Uric Acid is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma, or urine. The Uric Acid assay is a clinical chemistry assay in which uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide. The peroxide reacts with 4-aminoantipyrine and TBHB in the presence of peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 550 nm is proportional to the uric acid concentration in the sample.

The Abbott Laboratories Uric Acid assay is an in vitro diagnostic device for the quantitative determination of uric acid in human serum, plasma, or urine. The study presented demonstrates its substantial equivalence to predicate devices, namely the Roche Cobas Mira Plus Automated Chemistry Uric Acid assay (for serum) and the Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer (for urine).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the exact sample sizes used for the method comparison studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted using two levels of control material."

• Test Set Sample Size: Not explicitly stated for either method comparison or precision studies.
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be retrospective in the sense that they are comparing the performance of the new device against existing, established predicate devices using collected samples. No information suggests it was a prospective trial with patient enrollment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the study design focuses on a method comparison against predicate devices, not on a human-read diagnostic interpretation. The "ground truth" for the test set is established by the measurements obtained from the predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable as the study design is a method comparison, not an expert-based adjudication of diagnostic findings. The results from the predicate devices serve as the reference.

5. 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 information is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, this study essentially represents a standalone performance evaluation of the Uric Acid assay on the ALCYON 300/300i Analyzer. The "algorithm" here refers to the chemical assay method implemented on the analyzer. Its performance is evaluated independently against predicate methods, without human interpretation in the diagnostic process beyond setting up the samples and reviewing the quantitative results.

7. The Type of Ground Truth Used:

The ground truth for the method comparison studies was established by the measurements provided by the predicate devices:

• Roche Cobas Mira Plus Automated Chemistry Uric Acid assay for serum samples.
• Boehringer Mannheim Uric Acid assay on the Hitachi 717 Analyzer for urine samples.

For precision studies, the ground truth would be inferred from the known values of the control materials used.

8. The Sample Size for the Training Set:

This information is not applicable. This is an in vitro diagnostic assay based on established chemical reactions, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a device involves optimizing the biochemical reaction parameters and instrument settings during development.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the reasons stated in point 8. The development of such assays relies on biochemical principles rather than "ground truth" established from labeled data like in machine learning.

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Intended for the In Vitro, quantitative determination of Uric Acid in human serum and urine for clinical diagnosis.

"This 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", CFR 862.1775

TRACE !!!ric Acid - DST Reagent

The provided document is a 510(k) clearance letter from the FDA to TRACE America, Inc. for their Uric Acid - DST Reagent. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, study details, or performance data as requested in your prompt.

Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical trial report, or the 510(k) submission itself, which would typically include such details.

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