Search Results
Found 11 results
510(k) Data Aggregation
(241 days)
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.
Ask a specific question about this device
(154 days)
The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
Not Found
Here's an analysis of the acceptance criteria and study information for the Uric Acid (AOX) device based on the provided 510(k) summary:
This device is an IVD (In Vitro Diagnostic) and the criteria and performance metrics are related to analytical performance, not clinical performance metrics typical of AI/ML devices for diagnostic imaging studies. Therefore, many of the requested fields for AI/ML studies are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device K991576) | Reported Device Performance (Uric Acid (AOX)) |
|---|---|---|
| Measuring Range | Serum: 0 - 20 mg/dL | Serum: 0.2 - 20.0 mg/dl (10 - 1200 µmol/l) |
| Urine: 0 - 180 mg/dL | Not applicable (device does not test urine) | |
| Precision | Within Run: | Within Run: |
| Level 3.9 mg/dL: CV(%) = 1.1 | Level 1.2 mg/dL: CV(%) = 0.8 | |
| Level 8.6 mg/dL: CV(%) = 1.1 | Level 2.3 mg/dL: CV(%) = 0.7 | |
| Level 10.0 mg/dL: CV(%) = 0.6 | Level 4.4 mg/dL: CV(%) = 0.7 | |
| Level 8.9 mg/dL: CV(%) = 0.5 | ||
| Total Precision: | Between Run: | |
| Level 3.9 mg/dL: CV(%) = 1.9 | Level 1.2 mg/dL: CV(%) = 1.3 | |
| Level 8.6 mg/dL: CV(%) = 1.6 | Level 2.3 mg/dL: CV(%) = 0.9 | |
| Level 10.0 mg/dL: CV(%) = 2.3 | Level 4.4 mg/dL: CV(%) = 0.7 | |
| Level 8.9 mg/dL: CV(%) = 0.4 | ||
| Total Precision: | ||
| Level 1.2 mg/dL: CV(%) = 2.3 | ||
| Level 2.3 mg/dL: CV(%) = 1.7 | ||
| Level 4.4 mg/dL: CV(%) = 2.8 | ||
| Level 8.9 mg/dL: CV(%) = 1.1 | ||
| Method Comparison | Comparison to Technicon DAX: r = 0.994 | Comparison to Bayer ADVIA 2400: R = 0.999 |
| Range: 0.2 - 18.0 mg/dL | Range: 0.3 to 12.6 mg/dL | |
| N = 154 | N = 105 | |
| Comparison to Reference Method: r = 0.999 | ||
| Range: 1.7 - 19.5 mg/dL | ||
| N = 49 | ||
| Limitations | Hemolysate: No significant interference up | Lipemia: No interference up to 900 mg/dl |
| to 525 mg/dl of hemoglobin | Hemolysate: No interference up to 1000 mg/dl of hemoglobin | |
| Bilirubin: No significant interference up | Bilirubin conjugated: No interference up | |
| to 30 mg/dl | to 11 mg/dl | |
| Triglycerides: Effect measured | Bilirubin total: No interference up to | |
| 14 mg/dl |
Note: The acceptance criteria for the new device are implicitly demonstrated by showing comparable or better performance relative to the predicate device across the various analytical performance characteristics. The document doesn't explicitly state "acceptance criteria" but rather presents a comparison to the predicate, implying that performance similar to or better than the predicate is considered acceptable.
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison (Linearity/Correlation): N = 105 human serum/plasma samples (range 0.3 to 12.6 mg/dL).
- Precision: Not explicitly stated as "sample size" but rather "levels" tested (e.g., Level 1.2 mg/dL, 2.3 mg/dL, 4.4 mg/dL, 8.9 mg/dL) with corresponding SD and CV values. Typically, precision studies involve multiple replicates of control or patient samples.
- Limitations (Interference): Specific concentrations of interfering substances (Intralipid, hemoglobin, conjugated bilirubin, unconjugated bilirubin) were tested. The number of samples for each interference test is not explicitly stated.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "human serum or plasma" samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for an in vitro diagnostic (IVD) device that quantifies a biomarker (uric acid) using chemical reactions on an instrument. The "ground truth" for the test set is established by comparative measurements against a legally marketed predicate device (Bayer ADVIA 2400) and/or reference methods, not by expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
- Not applicable. See explanation for #3. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic decisions (e.g., in medical imaging).
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done
- No. This is an IVD device for quantitative measurement, not a diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study is not relevant to this submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, effectively. The performance data presented (measuring range, precision, method comparison, limitations) are measurements of the device's analytical performance on its own (algorithm/reagent/instrument combination) without human qualitative interpretation being a variable. The device provides a quantitative measurement, and its accuracy and precision are assessed directly.
7. The Type of Ground Truth Used
- Comparative Measurement to a Predicate Device and Traceability to a Primary Reference (NIST SRM 909b).
- Method Comparison: The device's results were compared to the Bayer ADVIA 2400 Chemistry System, which serves as a widely accepted "ground truth" for method comparison in IVD submissions.
- Traceability/Standardization: The value of Uric Acid (AOX) is stated to be assigned using NIST SRM 909b as a primary reference. The predicate device also establishes traceability to the CDC candidate reference method, which uses NIST reference materials. This indicates a strong chain of traceability to established analytical standards for ground truth.
8. The Sample Size for the Training Set
- Not explicitly stated/applicable in the context of this traditional IVD. Traditional IVDs like this do not typically use "training sets" in the same way machine learning algorithms do. The development process involves optimizing the reagent formulation and instrument parameters, which is an iterative process, but not framed as "training" with a specific data set.
9. How the Ground Truth for the Training Set Was Established
- Not explicitly stated/applicable. As mentioned above, the concept of a "training set" and establishing ground truth for it is not directly transferable to the development of this type of IVD device. The development relies on principles of analytical chemistry, reagent formulation, and instrument engineering to achieve accurate and precise measurements traceable to established standards.
Ask a specific question about this device
(264 days)
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
(43 days)
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.
Ask a specific question about this device
(31 days)
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.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Abbott Uric Acid assay) |
|---|---|---|
| Serum Application | ||
| Correlation Coefficient (vs. predicate) | High correlation (e.g., >0.99) | 0.9990 |
| Slope (vs. predicate) | Close to 1.0 (e.g., 0.95 - 1.05) | 1.074 |
| Y-intercept (mg/dL) (vs. predicate) | Close to 0.0 | 0.134 mg/dL |
| Precision (Total %CV Level 1/Panel 101) | Low %CV | 2.3% |
| Precision (Total %CV Level 2/Panel 102) | Low %CV | 1.3% |
| Linearity (up to) | Suitable for clinical range | 33.1 mg/dL |
| Limit of Quantitation (Sensitivity) | Clinically relevant | 0.2 mg/dL |
| Urine Application | ||
| Correlation Coefficient (vs. predicate) | High correlation (e.g., >0.99) | 0.9973 |
| Slope (vs. predicate) | Close to 1.0 (e.g., 0.95 - 1.05) | 0.999 |
| Y-intercept (mg/dL) (vs. predicate) | Close to 0.0 | 0.184 mg/dL |
| Precision (Total %CV Level 1/Panel 201) | Low %CV | 3.1% |
| Precision (Total %CV Level 2/Panel 202) | Low %CV | 1.8% |
| Linearity (up to) | Suitable for clinical range | 433.8 mg/dL |
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.
Ask a specific question about this device
(35 days)
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:
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Abbott Uric Acid Assay) | Target Material/Application |
|---|---|---|---|
| Correlation Coefficient | "similar clinical results" (to Roche) | 0.9918 | Serum |
| "similar clinical results" (to B-M) | 0.9854 | Urine | |
| Slope | Not explicitly stated, but implied as close to 1 | 0.981 | Serum |
| 0.951 | Urine | ||
| Y-intercept | Not explicitly stated, but implied as close to 0 | 0.599 mg/dL | Serum |
| 0.435 mg/dL | Urine | ||
| Total %CV (Precision) | Not explicitly stated, but implied as acceptable for diagnostic assays | Level 1: 2.8%Level 2: 2.3% | Serum |
| Level 1: 4.4%Level 2: 3.2% | Urine | ||
| Linearity | Not explicitly stated, but implied as relevant range | Up to 26 mg/dL | Not specified |
| Limit of Quantitation (Sensitivity) | Not explicitly stated, but implied as clinically relevant | 0.3 mg/dL | Not specified |
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.
Ask a specific question about this device
(34 days)
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.
Ask a specific question about this device
(42 days)
Ask a specific question about this device
(26 days)
Ask a specific question about this device
(90 days)
Ask a specific question about this device
Page 1 of 2