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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

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.

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The ATAC Calibrator Kit is intended for use with the ATAC Clinical Systems to establish points of reference that are used in the determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total bilirubin, total protein and urea in human specimens. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Calibrator Kit is intended to calibrate the ATAC Clinical Systems for the quantitative determination of albumin, calcium, cholesterol, creatinine, glucose, magnesium, phosphorus, total protein and urea nitrogen.

The provided document describes the ATAC Calibrator Kit and its performance in demonstrating substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for the regression statistics (e.g., specific ranges for slope and y-intercept). However, the implicit acceptance criterion is that the regression statistics demonstrate substantial equivalence to the comparative method, indicating accurate calibration.

Additionally, for reconstituted stability:

• Acceptance Criteria (Implicit): Statistically insignificant changes or changes less than round-off error/minimal clinical significance.
• Reported Device Performance:
  • Changes in albumin, magnesium, bilirubin, and total protein over 3 days at 2°C to 8°C were statistically insignificant or less than the round-off error of the assay.
  • Observed change for phosphorus over three days was less than 0.2 mg/dL.

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

• Test Set Sample Size:
  • Albumin: 59 sera
  • Magnesium: 55 sera
  • Phosphorus: 58 sera
  • Total Bilirubin: 54 sera
  • Total Protein: 52 sera
• Data Provenance: The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they involve assaying "at least 50 sera" for comparison with existing methods. It does not indicate the data is retrospective.

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

This type of study does not involve "experts" establishing ground truth in the way a medical imaging study might. Instead, the "ground truth" for the calibrator's performance is established by comparing its calibration results to those obtained using established, commercially available comparative methods with their respective calibrators and reagents. The document does not specify the qualifications of the individuals who performed these laboratory assays, but it would typically be trained laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative laboratory calibration study comparing results to established methods, not a subjective interpretation task requiring adjudication by multiple readers.

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 calibration study for an in vitro diagnostic device, not a study involving human readers or AI assistance.

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

Yes, this study essentially demonstrates the "standalone" performance of the ATAC Calibrator Kit in the context of the ATAC 8000 Random Access Chemistry System. It assesses the calibrator's accuracy by comparing results from the ATAC system (calibrated with the ATAC Calibrator) against established laboratory methods.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used is the results obtained from established, commercially available comparative methods (e.g., Hitachi 704, Beckman Synchron CX reagents) which themselves are calibrated with their respective, validated calibrators. This serves as the reference standard for evaluating the accuracy of the ATAC Calibrator Kit.

8. The Sample Size for the Training Set

Not applicable. This is a calibration and method comparison study, not a machine learning study that typically involves distinct training and test sets in the same way. The calibrator itself (ATAC Calibrator Kit) is used to establish reference points, and its accuracy is then validated against other calibrated methods. There isn't an "algorithm" being trained in the conventional sense.

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

Not applicable, as there isn't a "training set" in the context of a machine learning algorithm. The "ground truth" for the overall system's performance is established by the well-defined, validated methodologies of the comparative reference instruments and reagents.

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The ATAC Calcium Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitation of calcium in serum and plasma. Calcium results are for the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).

The ATAC Calcium Reagent Kit is intended for the quantitative determination of calcium in serum and plasma. Calcium results are for the diagnosis and treathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The ATAC Calcium Reagent determines calcium through binding by o-cresolphthalein complexone at alkaline pH. The resulting increase in absorbance at 578 nm is proportion al to the calcium concentration of the sample.

The provided text describes the ATAC Calcium Reagent Kit and studies demonstrating its performance. However, it does not explicitly define "acceptance criteria" as a set of specific thresholds for the reported performance metrics. Instead, it presents the results of various validation studies and implicitly suggests that these results are deemed acceptable for the device's intended use and demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, framed to address your request for acceptance criteria and the supporting study, even if the "acceptance criteria" are implied rather than explicitly stated.

Interpretation of Acceptance Criteria:

Given that this is a 510(k) submission, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to a predicate device (HiChem™ Calcium Reagent Kit) and proving that the device performs safely and effectively for its intended use. While explicit numerical cut-offs aren't listed as "acceptance criteria," the reported performance metrics in the studies are implicitly deemed acceptable by the manufacturer for this purpose.

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explicit "acceptance criteria" are not provided, the table below lists the performance parameters evaluated and their reported results. The implied acceptance is that these results are clinically acceptable and demonstrate substantial equivalence to the predicate device.

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The ATAC Creatinine 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 creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.

The ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The ATAC PAK Creatinines creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample.

The provided text describes the ATAC PAK Creatinine Reagent Kit and its performance characteristics. This is a medical device for in vitro diagnostic use, specifically a reagent kit for measuring creatinine levels. The information presented is typical for a 510(k) submission, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of in vitro diagnostic device (reagent kit), regulatory acceptance criteria typically revolve around accuracy, precision, linearity, and stability, often in comparison to a legally marketed predicate device. The document does not explicitly state "acceptance criteria" but rather presents the results of studies designed to demonstrate the device's performance.

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Ask a specific question about this device