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510(k) Data Aggregation
(241 days)
KNK
The ARCHITECT 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.
The Uric Acid assay is an in vitro diagnostic assay for use on the ARCHITECT c8000 System for the quantitative determination of uric acid in human serum, plasma, or urine using a uricase methodology. The Uric Acid assay is a two-part reaction. Uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide (H2O2). The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-sulfopropyl)-3-methoxy-5methylanaline (HMMPS) in the presence of peroxidase (POD) to yield a quinoneimine dye. The resulting change in absorbance at 604 nm is proportional to the uric acid concentration in the sample.
The two-part (R1/R2) configuration of this assay allows reduction of interference from ascorbic acid by inclusion of ascorbic oxidase in the R1 portion of the assay.
The provided text describes a medical device, the Architect Uric Acid assay, which is used for the quantitative determination of uric acid in human serum, plasma, or urine. The information focuses on its intended use, technological characteristics, and substantial equivalence to a previously marketed device (Abbott On-Market Uric Acid assay).
However, the provided text does not contain the specific details required to complete your request, such as a table of acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or results of MRMC or standalone studies.
The text emphasizes that the new device is "substantially equivalent" to the predicate device, implying that its performance is expected to be similar, but it does not present the specific acceptance criteria or the study data proving that it meets those criteria. The FDA letter confirms the device's substantial equivalence but also does not include the detailed performance data.
Therefore, I cannot fully answer your request based on the provided input.
If such information were available in the text, it would typically appear in a section detailing specific performance studies (e.g., precision, accuracy, linearity, interference studies) and their results, often compared against predefined acceptance limits.
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(193 days)
KNK
System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers
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.
Not Found
The provided text focuses on the FDA's 510(k) clearance of the Olympus Uric Acid Reagent, establishing its substantial equivalence to a predicate device. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.
Therefore, I cannot populate the table or provide specific answers to most of your questions based solely on the provided text. The document is a regulatory clearance letter, not a scientific study report.
Here's what I can extract and what is missing:
Information Present:
- Device Name: Olympus Uric Acid Reagent
- Intended Use: Quantitative determination of Uric Acid in human serum, heparinized plasma, and urine on OLYMPUS analyzers.
- Clinical Utility: Used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and patients receiving cytotoxic drugs.
- Regulatory Clearance: 510(k) clearance (K062862) issued on April 6, 2007.
Information NOT Present (and why it's typically in a study report, not a clearance letter):
- Acceptance Criteria and Reported Device Performance Table: The document doesn't list specific performance metrics (like accuracy, precision, linearity, limits of detection) or the thresholds for acceptable performance. It only states the device is substantially equivalent, implying its performance is comparable to an existing device.
- Sample Size for Test Set and Data Provenance: This information would be detailed in a validation study report.
- Number of Experts and Qualifications: Not relevant for a chemistry reagent validation; typically for image-based diagnostics where human interpretation is involved.
- Adjudication Method: Not relevant for a chemistry reagent.
- MRMC Comparative Effectiveness Study: Not relevant for a chemistry reagent. This applies to diagnostic tools where human interpretation is augmented by AI.
- Standalone Performance: While the "device" (reagent) performs standalone, the document doesn't provide the specific performance data.
- Type of Ground Truth Used: For a chemistry assay, the ground truth would typically be established using a reference method or certified reference materials with known uric acid concentrations. The document doesn't specify this.
- Sample Size for Training Set: Not applicable in the context of a chemical reagent validation in the same way it would be for a machine learning model.
- How Ground Truth for Training Set was Established: Again, not applicable as there's no "training set" in the machine learning sense for this type of device.
Conclusion:
The provided document is a regulatory approval letter. While it confirms the device's market readiness and intended use, it does not contain the detailed technical specifications or study results required to answer your specific questions about acceptance criteria and performance study design. This information would typically be found in the 510(k) submission summary or a separate validation study report, which is not included here.
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(13 days)
KNK
The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used for 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.
The Vitalab Uric Acid Reagent is a two-part for use with the Vitalab Selectra Analyzer. This reagent determines uric acid through enzymatic oxidation by uricase linked to a Trinder indicator reaction utilizing N-ethyl-N-(bydroxy-3sulfopropyl)-toluidine (TOOS) and 4-aminoantipyrine.
Here's a breakdown of the acceptance criteria and study information for the Vitalab Uric Acid Reagent, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Linear Range | Recovery of linearity standards that span the linear range, showing good correlation. | 0.1 to at least 25 mg/dL. |
| Regression: (Vitalab Recoveries) = 0 mg/dL + 1.027 x (Concentration), r = 0.999, s.y = 0.12 mg/dL, n = 40 | ||
| Detection Limit | Mean + two standard deviations of normal saline measurements should be rounded up to the smallest reportable value. | 0.1 mg/dL (mean + 2SD of normal saline measurements was 0.0 mg/dL, rounded up to the round-off error of the assay). |
| Precision | Replicate assay of commercially available control serum should demonstrate acceptable within-run and total precision (specific thresholds not explicitly stated but implied by acceptable results). | Serum 1 (2.5 mg/dL): Within Run: 1SD = 0.02, %CV = 0.7%; Total: 1SD = 0.04, %CV = 1.6% |
| Serum 2 (6.8 mg/dL): Within Run: 1SD = 0.04, %CV = 0.7%; Total: 1SD = 0.09, %CV = 1.4% | ||
| Serum 3 (11.1 mg/dL): Within Run: 1SD = 0.07, %CV = 0.6%; Total: 1SD = 0.13, %CV = 1.2% | ||
| Correlation | Good agreement with a "another commercially available method" (predicate device). Implied by a strong correlation coefficient and acceptable Deming regression statistics. | Serum: Selecta = 0.05 mg/dL + 0.995 x Competitive Reagent, r = 0.995, s.y = 0.08 mg/dL, n = 120 |
| Plasma: Selecta = 0.05 mg/dL + 0.995 x Competitive Reagent, r = 0.995, s.y = 0.08 mg/dL, n = 120 | ||
| Stability | All statistical estimates of total imprecision to be less than 0.2 mg/dL for claimed periods. | Onboard reagent stability: 14 days; Calibration stability: 7 days. Statistical estimates of total imprecision less than 0.2 mg/dL in all cases. |
2. Sample Size Used for the Test Set and Data Provenance
- Linear Range: n = 40 (number of recovery samples for linearity standards)
- Detection Limit: n = 30 (normal saline assays)
- Precision: n = 60 for each of the 3 serum samples (total 180 individual measurements).
- Correlation: n = 60 serum specimens and n = 60 heparinized plasma specimens (total n = 120 patient specimens).
- Data Provenance: The text states, "Sixty serum specimens ranging from 3.6 to 10.2 mg/dL uric acid and 60 heparinized plasma specimens ranging from 2.1 to 10.6 mg/dL uric acid were collected from adult patients..." This indicates the data is prospective (collected for the study) from adult patients, but the country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This device is a reagent for diagnostic testing, not an imaging or AI system that requires expert interpretation to establish ground truth for performance evaluation.
- The "ground truth" (or reference method) for the correlation study was "another commercially available method" (the predicate device). No human experts were explicitly involved in establishing "ground truth" in the manner of medical imaging interpretation.
4. Adjudication Method for the Test Set
- Not applicable. This is a chemical reagent and an analytical performance study, not an imaging or diagnostics study requiring adjudication of interpretations. The performance is assessed by comparing results to a reference method (the predicate device) or by intrinsic analytical measures (precision, linearity).
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
- Not applicable. This is a study of a chemical reagent, not an AI-based diagnostic tool requiring human-in-the-loop evaluation or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a study of a chemical reagent, not an algorithm. The performance described is the standalone analytical performance of the reagent on the Vitalab Selectra Analyzer.
7. The Type of Ground Truth Used
- Linear Range: The ground truth was based on the known concentrations of "linearity standards."
- Detection Limit: The ground truth was normal saline (assumed to have 0 mg/dL uric acid).
- Precision: The ground truth was the known mean concentration of "commercially available control serum."
- Correlation: The ground truth was established by the results from a "another commercially available method" (the predicate device). This serves as the reference method against which the new device's performance is compared.
8. The Sample Size for the Training Set
- Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set." The performance characteristics are determined through analytical testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for a chemical reagent.
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(105 days)
KNK
The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.
The provided text describes the ATAC PAK Uric Acid Reagent Kit and its performance studies as part of a 510(k) submission. It's important to note that this is a diagnostic reagent, not an AI-based device, so some of the requested categories (like "effect size of how much human readers improve with AI vs without AI assistance" or "adjudication method") are not applicable in the context of this product. I will address the relevant information as presented in the document.
Acceptance Criteria and Reported Device Performance for ATAC PAK Uric Acid Reagent Kit
The studies were conducted to demonstrate the substantial equivalence of the ATAC PAK Uric Acid Reagent Kit to a legally marketed predicate device (Roche Uric Acid Reagent Kit) on the ATAC 8000 Random Access Chemistry System.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear recovery across the usable range (0.2 to 25 mg/dL) with strong correlation to standard values. | The recovery of uric acid is linear from 0.2 to 25 mg/dL. |
| Regression statistics: (ATAC Recoveries) = 0.996 x (Standard Value), r = 0.9998, sy.x = 0.18 mg/dL, n = 30. | ||
| Precision (Within Run) | Low coefficient of variation (CV) and standard deviation (1SD) for control samples. | Serum 1 (mean 2.3 mg/dL): 1SD = 0.12 mg/dL, %CV = 5.0% |
| Serum 2 (mean 6.9 mg/dL): 1SD = 0.16 mg/dL, %CV = 2.3% | ||
| Serum 3 (mean 11.3 mg/dL): 1SD = 0.19 mg/dL, %CV = 1.7% | ||
| Precision (Total) | Low coefficient of variation (CV) and standard deviation (1SD) for control samples across multiple runs/days. | Serum 1 (mean 2.3 mg/dL): 1SD = 0.23 mg/dL, %CV = 9.8% |
| Serum 2 (mean 6.9 mg/dL): 1SD = 0.30 mg/dL, %CV = 4.4% | ||
| Serum 3 (mean 11.3 mg/dL): 1SD = 0.38 mg/dL, %CV = 3.4% | ||
| Method Comparison | Strong correlation and agreement with a commercially available comparative method. | Regression statistics: ATAC 8000 = - 0.11 mg/dL + 0.987 x Competitive Reagent, syx = 0.29 mg/dL, n=120, range = 1.8 - 18.8 mg/dL. |
| Detection Limit | Low detection limit, accurately determined. | 0.2 mg/dL. Documented by repetitive assay of a diluted serum pool; observed standard deviation of a 30-replicate within-run precision study was 0.1 mg/dL. The detection limit is reported as twice the round-off error of the assay (implying 0.1 mg/dL * 2 = 0.2 mg/dL). |
| Reagent Stability | Observed change in control recoveries less than 0.3 mg/dL over 14 days. | The observed change in control recoveries was less than 0.3 mg/dL over the claimed 14-day on-board reagent stability period. |
| Calibration Stability | Total imprecision of uric acid recoveries less than 0.3 mg/dL or 5% over 3 days. | The total imprecision of uric acid recoveries over the test periods was less than 0.3 mg/dL or 5% over the claimed 3-day calibration stability period. |
2. Sample sizes used for the test set and the data provenance
- Linearity/Recovery: n = 30 (for regression statistics, representing standard values/recoveries). No information on provenance (e.g., country of origin, retrospective/prospective) is provided, but it pertains to the behavior of the reagent with known standard concentrations.
- Precision: n = 60 for each of the three serum control samples. This implies 60 replicate measurements for each control. No information on provenance for these commercially available control sera.
- Method Comparison: n = 120 (mixed serum and plasma specimens). No information on country of origin. The data provenance is described as "collected from adult patients," suggesting prospective or freshly collected samples for the purpose of the study.
- Detection Limit: n = 30 (for within-run precision study of a diluted serum pool).
- Reagent Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.
- Calibration Stability: "serum controls" assayed over the claimed periods. Specific 'n' not given, but likely multiple measurements of controls.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a chemical assay, not an imaging device requiring expert interpretation. The "ground truth" for linearity and precision is based on known concentrations of standards and control materials. For method comparison, the "ground truth" is established by a "commercially available method" (the competitive reagent), and the goal is to show agreement between the two methods, rather than an expert ground truth.
4. Adjudication method for the test set
Not applicable. As noted above, this is a chemical assay.
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
Not applicable. This is a diagnostic reagent, not an AI-based system or an imaging device requiring human reader interpretation. No AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The performance data presented are for the "ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System." This represents the standalone performance of the reagent kit and analyzer system in determining uric acid levels in samples. Human involvement is limited to operating the instrument, performing calibration/quality control, and interpreting quantitative numerical results provided by the system.
7. The type of ground truth used
- Linearity/Recovery: Known concentrations of "linearity standards."
- Precision: Assays of "commercially available control serum" with expected target ranges/values.
- Method Comparison: Results from a "commercially available method" (predicate device or similar). This serves as the reference for comparison, rather than an absolute "ground truth" in the sense of pathology or outcome data.
- Detection Limit: A "diluted serum pool" and its statistical properties.
- Stability Studies: "Serum controls" with known target values.
8. The sample size for the training set
Not applicable. This is a chemical reagent and analyzer system, not an algorithm that requires a "training set." The system's operation is based on established chemical principles and pre-programmed instrument parameters, not machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
Ask a specific question about this device
(264 days)
KNK
The Bayer ADVIA IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation and other wasting conditions and of patients receiving cytotoxic drugs.
Not Found
Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Uric Acid method, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary directly presents performance data for the ADVIA IMS Uric Acid method and compares it to a predicate device (ADVIA 1650 Uric Acid) and/or a comparison system (CDC Uricase). While explicit "acceptance criteria" are not stated as defined thresholds (e.g., "CV must be less than X%"), the reported performance demonstrates "substantial equivalence" to the predicate, implying that these levels of performance were acceptable for clearance.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Comparison) | Reported ADVIA IMS Performance |
|---|---|---|
| Imprecision (Serum) | Similar or better CV (%) than ADVIA 1650 | |
| Level 3.7 mg/dL | ADVIA 1650: 1.9% CV | 2.3% CV |
| Level 7.7 mg/dL | ADVIA 1650: 1.6% CV | 1.6% CV |
| Level 9.9 mg/dL | ADVIA 1650: 2.3% CV | 1.1% CV |
| Imprecision (Urine) | Similar or better CV (%) than ADVIA 1650 | |
| Level 20.2 mg/dL | ADVIA 1650: 2.3% CV (for 12.4 mg/dL) | 5.2% CV |
| Level 28.9 mg/dL | ADVIA 1650: 5.2% CV (for 23.9 mg/dL) | 3.6% CV |
| Level 38.4 mg/dL | (N/A - no direct predicate comparison at this level) | 2.6% CV |
| Correlation (Serum, vs. CDC Uricase) | High correlation (R close to 1), Syx low | Y=0.98X+0.11, Syx=0.27, R=0.999 |
| Correlation (Serum, vs. Advia 1650) | High correlation (R close to 1), Syx low | Y=0.96X+0.29, Syx=0.37, R=0.998 |
| Correlation (Plasma vs. Serum, via Advia 1650) | High correlation (R close to 1), Syx low | Y=1.01X-0.05, Syx=0.08, R=0.998 |
| Correlation (Urine, vs. CDC Uricase) | High correlation (R close to 1), Syx low | Y=1.035X-0.37, Syx=1.11, R=0.999 |
| Correlation (Urine, vs. Advia 1650) | High correlation (R close to 1), Syx low | Y=0.96X-1.08, Syx=2.70, R=0.998 |
| Interfering Substances | Minimal clinically significant change (e.g., well within +/-10%) | Most effects within +/-7% |
| Analytical Range (Serum) | Comparable to predicate for intended use | 0-26 mg/dL |
| Analytical Range (Urine) | Comparable to predicate for intended use | 0-230 mg/dL |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
- Imprecision Study (Serum): The "Level (mg/dL)" values suggest multiple measurements were taken at three different concentrations, but the exact number of replicates or individual samples is not provided.
- Imprecision Study (Urine): Similar to serum, the exact number of replicates or individual samples is not provided.
- Correlation Studies:
- Serum vs. CDC Uricase: N = 117
- Serum vs. Advia 1650: N = 100
- Plasma (Y) vs. Serum (X) with Advia 1650: N = 54
- Urine vs. CDC Uricase: N = 10
- Urine vs. Advia 1650: N = 63
- Interfering Substances: The Uric Acid Conc. (mg/dL) values suggest testing at specific concentrations, but the number of samples for each interferent is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. For in vitro diagnostic devices like this, "ground truth" is typically established by reference methods or validated comparative systems (e.g., CDC Uricase), rather than by human expert consensus or pathology review in the same way it would be for an imaging-based AI device.
4. Adjudication Method for the Test Set
This is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI devices that assist human diagnosticians (e.g., CAD systems for radiology). The ADVIA IMS Uric Acid method is a standalone laboratory instrument for quantitative measurement, not an AI assisting human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance studies of the ADVIA IMS Uric Acid method. The device measures uric acid levels automatically; there is no "human-in-the-loop" once the sample is loaded and the test initiated. The performance metrics (imprecision, correlation, interference) directly reflect the algorithm's and instrument's capabilities.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the test set was established using:
- Reference Methods: The "CDC Uricase" method is cited as a comparison system for correlation studies in both serum and urine. This is a highly accurate and standardized reference method for uric acid measurement.
- Predicate Device/Comparative System: The "Advia 1650" (the predicate device) was used as a comparison system for imprecision, correlation, and for comparing plasma vs. serum. This indicates that the performance of the new device was benchmarked against an already legally marketed and accepted method.
8. The Sample Size for the Training Set
This is not applicable in the context of this device. The ADVIA IMS Uric Acid method is an enzymatic assay based on established biochemical principles, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance is characterized through analytical validation studies using patient samples and quality controls, which are the "test sets" described above.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, this is not applicable because the device does not employ machine learning or AI that would necessitate a "training set" with ground truth established through, for example, expert annotation. The device's underlying chemistry and optical detection principles are well-understood and do not require iterative training.
Ask a specific question about this device
(48 days)
KNK
The Wiener lab. Uricostat enzimático AA Líquida. test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum 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 under treatment with cytotoxic drugs.
End point method. The principle is based on the following reaction system: UOD Uric Acid + 2 H2O + O2- -> Allantoin + H2O2 + CO2 POD 2 H2O2 + 4-AP + 3,5-SDH ------------------------------------------------------------------------------------------------------------------------------------------------------ The amount of uric acid is determined by measuring the absorbance of this pigment. UOD: Uricase; POD: Peroxidase; 4-AP: 4-Aminophenazone; 3,5-DHS: 3,5-dichlorohydroxybenzenesulfonic acid, sodium salt.
The provided document describes the Wiener lab. Uricostat enzimático AA Líquida, an in vitro diagnostic device for determining uric acid levels. The document primarily focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study demonstrating device performance in the context of clinical acceptance criteria typical for AI/ML-based medical devices.
Therefore, the requested information elements related to AI/ML device testing (such as ground truth, expert adjudication, MRMC studies, training set details) are not applicable or available in this document. The information provided outlines the analytical performance of the device.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document serves as a 510(k) summary, which establishes substantial equivalence to a predicate device. The performance claims are primarily based on equivalence to the predicate and analytical performance. Explicit "acceptance criteria" for clinical utility in the context of a new AI/ML device are not stated, but rather, performance metrics compared to the predicate device are presented.
| Acceptance Criteria (Implied for Analytical Performance) | Reported Device Performance (Uricostat enzimático AA Líquida) |
|---|---|
| Intended Use | Enzymatic method for the determination of uric acid in serum or plasma. |
| Test Principle | End point method using Uricase and Peroxidase reactions, measuring absorbance of red quinonimine. |
| Reagents | Standard: uric acid. |
| Reagent 1: Good buffer - DHS. | |
| Reagent 2: Good buffer. Reagents can be used separately or as Monoreagent (4 parts Reagent 1 + 1 part Reagent 2). | |
| Preparation of Working Reagent | Reagents may be used separately or as Monoreagent, mixing 4 parts of Reagent 1 + 1 part of Reagent 2. (Predicate required dissolution of an enzyme vial in a buffer bottle). |
| Stability of Final Color | (Not specified for new device, predicate was 30 minutes. Implied similar or better.) |
| Wavelength of Reading | 505 nm in spectrophotometer or 490-530 nm in photocolorimeter with green filter. |
| Calibration | Single point. |
| Linearity | 20 mg/dl (This value represents the upper limit of linearity). |
| Within-run precision (CV) | Normal Level Serum: CV = 2.21% |
| High Level Serum: CV = 1.32% | |
| Run-to-run precision (CV) | Normal Level Serum: CV = 2.86% |
| High Level Serum: CV = 1.90% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the precision and linearity studies, nor does it provide details on the provenance of the samples (e.g., country of origin, retrospective or prospective). This information is typically found in detailed validation reports, not in a 510(k) summary focused on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a quantitative in vitro diagnostic test for measuring uric acid, not an AI/ML device requiring expert interpretation of complex data for ground truth establishment. Its performance is evaluated against reference methods or established analytical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring human adjudication of ground truth.
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
Not applicable. This device is an analytical test that measures a biochemical parameter, not a system that assists human readers in interpreting images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the inherent performance of the Uricostat enzimático AA Líquida test system itself. The precision and linearity data represent the standalone analytical performance of the device without human intervention in the result generation (though human operators would perform the assay).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For an in vitro diagnostic device like this, "ground truth" would typically refer to:
- Reference materials: Control sera with known concentrations of uric acid.
- Reference methods: Comparison with a gold standard analytical method for uric acid measurement.
- Known concentrations: Spiking samples with known amounts of uric acid for linearity studies.
The document implicitly uses these types of "ground truth" for its analytical performance claims (e.g., "Normal Control," "Abnormal Control," "Normal Level Serum," "High Level Serum" for precision, and implied known concentrations for linearity).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in that context. The development of the reagents and assay would have involved optimization, but not "training data" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
Ask a specific question about this device
(53 days)
KNK
Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers.
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.
Not Found
I am sorry, but based on the provided document, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not available. This document is an FDA 510(k) clearance letter for a Uric Acid Reagent, which states that the device is substantially equivalent to legally marketed devices and can proceed to market. It does not contain details about specific acceptance criteria or a study proving that the device meets those criteria.
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(60 days)
KNK
Ask a specific question about this device
(27 days)
KNK
Intended for measure uric acid in serum, plasma and are used in the obtain and urine. Measurements 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.
The Wako L-Type UA F Test is an in vivo assay for the quantitative determination of uric acid in serum and plasma. The Wako L-Type UA F is a method utilizing uricase, N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS) and 4-aminoantipyrine.
Here's a breakdown of the acceptance criteria and study information for the Wako L-Type UA F Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Method Comparison | Correlation Coefficient (vs. predicate) | High correlation (e.g., >0.9) | 0.970 |
| Regression Equation (vs. predicate) | Close to y = x | y = 1.028x - 0.34 | |
| Precision | Reproducibility/Consistency | Acceptable values | Acceptable values can be obtained on a day-to-day basis |
| Sensitivity | Minimum Detectable Level (LOD) | Undefined | 0.2 mg/dL |
Note: The document explicitly states "The safety and effectiveness of the Wako L-Type UA F Test is demonstrated by its substantial equivalency to the Wako UA 30R Uric Acid product." Therefore, the predicate device's performance serves as the de facto acceptance criteria for comparing method performance. The acceptance criteria for precision and minimum detectable level are not explicitly stated as numerical targets in this summary, but rather implied by the statement of "acceptable values" and the reporting of the LOD.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the method comparison study. The document only mentions "In comparison studies against the predicate assay."
- Data Provenance: Not specified. It does not mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker. The ground truth would typically be established by the reference method (the predicate device in this case), not by expert human graders.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is an IVD device measuring a biochemical parameter, not an imaging or diagnostic device that involves human reader interpretation. Therefore, an MRMC study is not relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "comparison studies against the predicate assay" represent a standalone performance evaluation of the Wako L-Type UA F Test. It measures the device's output (uric acid concentration) and compares it directly to the output of the predicate device.
7. The Type of Ground Truth Used:
- Predicate device's measurements. The ground truth for evaluating the Wako L-Type UA F Test's performance in the comparison study was the results obtained from the "Wako UA 30R Uric Acid product." This is a common approach for establishing substantial equivalence for new IVD assays.
8. The Sample Size for the Training Set:
- Not applicable / Not stated. For an in vitro diagnostic assay like this, there isn't typically a "training set" in the sense of machine learning. The development of the assay's reagents and methodology would involve internal R&D, but the document does not describe a separate "training set" with associated ground truth as one would for an AI/ML diagnostic.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As noted above, the concept of a training set for an AI/ML algorithm doesn't directly apply here. The fundamental principles of the assay rely on established biochemical reactions (enzymatic oxidation, colorimetric measurement) rather than a trained algorithm. The "ground truth" for developing such a test is the accurate biochemical quantification of uric acid.
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The Uric Acid reagent, product No. UA112-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of Uric Acis in serum, or plasma.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Uric Acid reagent. It primarily focuses on the regulatory approval and substantial equivalence to a predicate device. It does not contain information typically found in a study report, such as:
- Specific acceptance criteria and reported device performance: The letter states the device is "substantially equivalent" but provides no performance metrics or criteria.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Result of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- Method for establishing training set ground truth.
Therefore, I cannot extract the requested information from the provided document as it does not contain the details of a performance study.
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