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The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is intended for use with the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of conjugated bilirubin in serum and plasma. Conjugated bilirubin results are used for the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Direct Bilirubin Reagent Kit, which contains both reagent and calibrator, is substantially equivalent to the Trace Direct Bilirubin Reagent, product UG38 (Trace Scientific, Ltd. of Melbourne, Australia) calibrated with the Sigma Bilirubin Calibrator, Total and Direct, product no. B8652 (Sigma Diagnostics, Inc. St. Louis, MO). The effectiveness of ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown in the following studies.

The ATAC Direct Bilirubin Reagent determines conjugated bilirubin through its reaction with diazotized sulfanilic acid to form a red-purple complex. The resulting increase in absorbance at 546 nm is proportional to the direct bilirubin concentration in the sample.

This document describes the acceptance criteria and performance of the ATAC Direct Bilirubin Reagent Kit, a device intended for the quantitative determination of conjugated bilirubin in serum and plasma.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the provided text. However, the reported device performance demonstrates the device's characteristics, which would implicitly meet internal acceptance based on established analytical standards for diagnostic reagents. We can infer the "acceptance" by the fact that these results are presented as evidence of the device's effectiveness and substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Linearity: n = 18 (for standard factor recoveries).
• Sample Size for Precision: n = 60 for each of the three control serum levels (total 180 assays)
• Sample Size for Method Comparison: n = 96 (after exclusions).
• Sample Size for Detection Limit: 125 results over 25 runs.
• Data Provenance: The document states that mixed serum and plasma specimens were collected from adult patients. The country of origin is not explicitly stated, but the predicate device is from Trace Scientific, Ltd. of Melbourne, Australia, and Sigma Diagnostics, Inc. St. Louis, MO, for the calibrator, suggesting a US/Australian context. The study appears to be prospective in nature, as indicated by the collection of patient specimens for the method comparison and repeated assays for precision and detection limit.

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

This device is an in vitro diagnostic reagent kit for quantitative determination of a biomarker (conjugated bilirubin). The "ground truth" for such devices is typically established through reference methods or highly accurate analytical techniques, not through expert human interpretation of images or clinical cases. Therefore:

• Number of Experts: Not applicable in the context of this type of diagnostic device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving subjective interpretations (e.g., imaging studies where multiple readers interpret results and discrepancies need to be resolved). For a quantitative chemical assay, the "adjudication" is inherent in the analytical methodology itself, such as repeat measurements, statistical analysis, and comparison to a predicate device or reference method.

• Adjudication Method: Not applicable in the traditional sense. The method comparison study involved comparing the ATAC 8000 results with those from another commercially available method, and statistical analysis (Deming regression) was used to assess agreement. Outliers were excluded based on statistical criteria (poor reproducibility and residuals exceeding 6 standard errors).

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

• Was an MRMC study done? No. This type of study is relevant for devices involving human interpretation of results, such as imaging diagnostics. This is a quantitative chemical assay that provides a numerical output.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, the entire evaluation presented (linearity, precision, method comparison, detection limit, stability) represents the standalone performance of the ATAC Direct Bilirubin Reagent Kit on the ATAC 8000 Random Access Chemistry System. This is an automated system; once the sample is loaded, the measurement is performed by the instrument and reagents without real-time human intervention in the result generation process.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Reference Standards: For linearity, the ground truth was established by "standard values" which are specific concentrations of conjugated bilirubin used for calibration curves.
  • Commercially Available Control Serum: For precision, the ground truth was the expected range of values for these control sera.
  • Comparison to a Predicate Device/Method: For method comparison, the ground truth was established by "another commercially available method" (the "Competitive Reagent"). This approach demonstrates substantial equivalence, where the predicate serves as the de facto "ground truth" for comparative performance.
  • Diluted Serum Pool: For the detection limit, the ground truth involved a diluted serum pool to assess the lowest measurable concentration.

8. The Sample Size for the Training Set

This document describes the validation of a chemical reagent kit, not a machine learning or AI-based algorithm that typically uses "training sets." The linearity standards, control sera, and patient samples used in the performance studies are for validation/testing, not for "training" the reagent itself.

• Sample Size for the Training Set: Not applicable.

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

As there is no "training set" in the context of this device, this question is not applicable. The device's operational parameters (e.g., absorbance at 546 nm proportional to concentration) are based on established chemical principles, not on a trained algorithm.

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The ATAC Total Bilirubin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results are used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

The ATAC Total Bilirubin Reagent determines total bilirubin through its reaction with diazotized sulfanilic acid in the presence of dimethylsulfoxide to form a red-purplex. The resulting increase in absorbance at 546 nm is proportional to the total bilirubin concentration in the sample.

The "ATAC Total Bilirubin Reagent Kit" is a device intended for the quantitative determination of total bilirubin in serum and plasma. The following information outlines its acceptance criteria and the studies performed to demonstrate its effectiveness.

1. Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set for Linearity: n = 18 (for the linear regression of standard factors). The data provenance is not explicitly stated as country of origin, but it is for "linearity standards," implying laboratory-prepared standards.
• Test Set for Precision: n = 36 for each of the three serum samples tested (total of 108 replicates). The data provenance is "commercially available control serum."
• Test Set for Method Comparison: n = 107. The data provenance is "Mixed serum and plasma specimens, collected from adult patients." The country of origin is not specified. It is likely prospective for the purpose of the study.
• Test Set for Detection Limit: 30 replicates of a diluted serum pool.

3. Number of Experts and Qualifications for Ground Truth

• This document describes the performance characteristics of an in-vitro diagnostic reagent kit (ATAC Total Bilirubin Reagent Kit) and does not involve image analysis or clinical interpretation by human experts to establish ground truth in the typical sense for a medical device that outputs diagnoses or classifications.
• The ground truth for the performance studies (linearity, precision, method comparison, detection limit, stability) is based on:
  • Known concentrations for linearity standards.
  • Assigned values for commercially available control serum.
  • Results from a "commercially available method" (predicate device or similar) for method comparison.
• Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as it applies to image interpretation or clinical diagnosis does not directly apply here. The "experts" are the analytical chemists and laboratory professionals who establish the values of standards and controls, and run the comparative assays.

4. Adjudication Method

• Adjudication methods like 2+1 or 3+1 are typically used in studies where there is subjective human interpretation involved (e.g., radiologists reviewing images).
• For the performance studies of this in-vitro diagnostic reagent, the "ground truth" or reference values are established through quantitative chemical analysis and metrological traceability. Therefore, an adjudication method in the human consensus sense is not applicable. Discrepancies would be resolved through re-testing, calibration verification, or investigation of analytical errors, not expert consensus.

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

• An MRMC study is not mentioned and is not applicable to the evaluation of an in-vitro diagnostic reagent kit like the ATAC Total Bilirubin Reagent Kit. These studies are relevant for devices that assist human readers in tasks like image interpretation or clinical decision-making.

6. Standalone Performance

• Yes, this document primarily reports on the standalone performance of the ATAC Total Bilirubin Reagent Kit when used with the ATAC 8000 Random Access Chemistry System. The results presented (linearity, precision, detection limit, stability) are measures of the algorithm's (reagent kit's) performance independent of human-in-the-loop diagnostic interpretation.
• The "method comparison" study essentially compares the standalone performance of the ATAC kit to another standalone, commercially available method.

7. Type of Ground Truth Used

The types of ground truth used are:

• Reference Standards/Known Concentrations: For linearity and stability studies, the performance is evaluated against solutions with established concentrations of total bilirubin.
• Assigned Values of Control Materials: For precision studies, the device's repeatability and reproducibility are measured against commercially available control sera with pre-determined mean values.
• Results from a Legally Marketed Predicate/Comparative Device: For method comparison, the results from the ATAC Total Bilirubin Reagent are compared against those obtained from the "Beckman Synchron Total Bilirubin Reagent, product 442745" or another "commercially available method," which serves as the reference ground truth for agreement.

8. Sample Size for the Training Set

• This document describes validation studies of a chemical reagent kit, not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI is not applicable. The development of the reagent itself would involve formulation, optimization, and initial testing, but these are not referred to as "training sets."

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

• As the concept of a "training set" for an AI model is not applicable here, the question of how its ground truth was established is also not relevant. The studies focus on verifying the analytical performance of the finished reagent kit against established laboratory and regulatory standards.

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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.

Details of the Study Proving Device Meets Acceptance Criteria:

The provided document describes a series of studies performed to demonstrate the safety and effectiveness, and specifically the substantial equivalence, of the ATAC Calcium Reagent Kit to a legally marketed predicate device (HiChem™ Calcium Reagent Kit).

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

• Linearity Study:
  • Sample Size: n = 21 (number of regression points/standards).
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared linearity standards.
• Precision Study:
  • Sample Size: n = 60 for each of the three serum control levels (total 180 individual measurements for precision). These 60 measurements were likely split across two instruments as mentioned ("on two separate instruments").
  • Data Provenance: Commercially available control serum.
• Method Comparison Study:
  • Sample Size: n = 120 patient specimens.
  • Data Provenance: Mixed serum and plasma specimens collected from adult patients. The country of origin is not specified but is presumably the US, given the FDA submission. This is a prospective or retrospective collection of patient samples, but the method comparison itself is a prospective analysis.
• Detection Limit Study:
  • Sample Size: 30 replicates for a within-run precision study.
  • Data Provenance: A diluted serum pool.

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 document. For in vitro diagnostic devices like reagent kits, "ground truth" is typically established by:

• Using reference materials (e.g., for linearity).
• Using validated control materials with known target values (e.g., for precision).
• Comparing against a predicate device or a well-established, clinically accepted method (e.g., for method comparison).
• Pathology or outcome data are not directly applicable here as it's a quantitative measurement of a biomarker.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies where subjective interpretation by multiple readers is involved to establish a consensus ground truth. For a quantitative chemistry assay, the "ground truth" for validation is based on the inherent properties of the reference materials/controls or the results from a comparison method.

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 therefore not provided. MRMC studies are specific to imaging and AI-assisted interpretation, where human readers interact with AI. The ATAC Calcium Reagent Kit is a standalone chemical assay, not an imaging device or an AI-powered diagnostic tool requiring human interpretation.

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

Yes, the studies described are solely for the standalone performance of the ATAC Calcium Reagent Kit on the ATAC 8000 Random Access Chemistry System. There is no human-in-the-loop component in the "performance" described; it's the analytical performance of the reagent and instrument system.

7. The Type of Ground Truth Used:

• For Linearity: The ground truth was established by standard values of linearity standards.
• For Precision: The ground truth was established by the labeled target values of commercially available control serum.
• For Method Comparison: The ground truth was effectively established by the results from a "competitive reagent" (another commercially available method), which serves as the reference method in this comparison to demonstrate substantial equivalence.
• For Detection Limit: The ground truth was established by the known dilution of a serum pool and the statistical variation measured at that low concentration.

8. The Sample Size for the Training Set:

This information is not applicable and therefore not provided. This device is a chemical reagent, not a machine learning or AI model that requires a "training set" in the computational sense. The "development" or "optimization" of such a reagent kit might involve many experiments, but these are not referred to as a "training set" in this context.

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

This information is not applicable as there is no "training set" in the context of this device.

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The ATAC PAK Magnesium Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of magnesium in serum and plasma. Magnesium results are used for the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

The ATAC PAK Magnesium Reagent determines magnesium through its selective binding by xylidyl blue to form a red-purple chelate. The resulting increase in absorbance at 510 nm is proportional to the magnesium concentration in the sample.

The provided text describes the ATAC PAK Magnesium Reagent Kit, its intended use, and studies demonstrating its performance and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format. However, it presents performance metrics that implicitly serve as acceptance criteria by demonstrating equivalence to a legally marketed device and adequate performance for its intended use. Based on the provided data, the implicit acceptance criteria and the device's performance are summarized below:

Study Information:

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

   • Linearity Study: n = 36 (for regression analysis of standards). The document does not specify the country of origin but implies laboratory-prepared standards.
   • Precision Study: n = 60 replicates for each of the three serum samples. The control serum is commercially available, but its origin and whether the testing was prospective or retrospective are not specified.
   • Method Comparison Study: n = 110 mixed serum and plasma specimens. These were collected from adult patients, implying a clinical setting. Country of origin not specified, and whether it was prospective or retrospective is not explicitly stated.
   • Detection Limit Study: n = 30 replicates of a diluted serum pool.
   • Stability Studies: Serum controls were assayed, but the specific number of samples or replicates for these studies is not provided beyond "average changes."

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

   • This device is a quantitative assay for magnesium in serum and plasma, not an AI or imaging device that typically requires expert interpretation for a "ground truth" label.
   • For the linearity study, the "ground truth" is the known concentration of the linearity standards.
   • For the precision study, the "ground truth" is the mean concentration of the commercially available control serum.
   • For the method comparison study, the "ground truth" is established by the results obtained from the legally marketed predicate device (Beckman Synchron Magnesium Reagent). No human experts are involved in establishing this "ground truth" in the context of this type of analytical method validation.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving subjective interpretation (e.g., radiology reads) where multiple human readers resolve disagreements. This product is an in-vitro diagnostic reagent, where results are quantitative measurements.

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:

   • Not applicable. This is an in-vitro diagnostic (IVD) reagent kit, not an AI or imaging device where human readers interact with AI assistance. The study compares the new reagent's performance against a predicate device and its own analytical characteristics.

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

   • Yes, the studies described are standalone performance evaluations of the ATAC PAK Magnesium Reagent Kit when used with the ATAC 8000 Random Access Chemistry System. This is a chemical assay, and its performance is assessed directly through its analytical capabilities without human-in-the-loop interaction for result generation. The human "in-the-loop" would be the laboratory personnel operating the instrument and interpreting the numerical results.

6. The type of ground truth used:

   • Reference standards/known concentrations for linearity.
   • Assigned values/agreement with the predicate device for precision and method comparison.
   • Experimental observation (e.g., standard deviation of replicates) for detection limit.

7. The sample size for the training set:

   • Not applicable. This is a chemical reagent kit, not an AI algorithm that requires a "training set" in the machine learning sense. The "development" of the reagent would involve chemical formulation and optimization, not data training.

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

   • Not applicable, as there is no "training set" in the context of an IVD reagent.

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The ATAC PAK Phosphorus Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC PAK Phosphorus Reagent Kit, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note on "Acceptance Criteria (Implied)": The document performs a substantial equivalence claim against an existing device (Beckman Synchron Phosphorus Reagent). Therefore, the "acceptance criteria" are not explicitly stated as hard numerical thresholds within this document, but rather are demonstrated by showing performance comparable to, or within acceptable limits for, clinical laboratory assays of this type, often implicitly benchmarked against the predicate device or established industry guidelines (like NCCLS EP3-T for precision). For regression analyses, slopes near 1, intercepts near 0, and high correlation coefficients (r-values) are generally considered good.

2. Sample sized used for the test set and the data provenance

• Linearity: 27 samples (implied from "n=27" associated with linearity regression, though the context indicates "% of the rod" which is a typo and likely meant "range" or "rod" as a unit for linearity standards). The samples used were "linearity standards that span the usable range."
• Precision:
  • Serum 1: n = 60 replicates
  • Serum 2: n = 60 replicates
  • Serum 3: n = 60 replicates
    The samples were "commercially available control serum."
• Method Comparison: n = 115 patient specimens. The specimens were "Mixed serum and plasma specimens, collected from adult patients." The data provenance is not explicitly stated as country of origin, but it is retrospective as the specimens were already collected.
• Detection Limit: 30 replicates of a diluted serum pool.

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

This information is not provided in the document. For an in vitro diagnostic (IVD) like a phosphorus reagent, "ground truth" is typically established by:

• Reference methods for linearity standards.
• Certified values for control sera used in precision studies.
• The results from a well-established, legally marketed comparative method (predicate device) in method comparison studies.
  No human experts are explicitly mentioned as establishing ground truth in this context; rather, the "truth" is derived from established analytical methods and reference materials.

4. Adjudication method for the test set

Not applicable. The "adjudication method" (e.g., 2+1, 3+1) typically refers to a process where multiple human readers independently interpret data, and discrepancies are resolved by a consensus or a senior expert. This concept is relevant for imaging or diagnostic algorithms where human interpretation is the primary ground truth. For an IVD reagent, the performance is assessed against quantitative analytical metrics, not human adjudication of results.

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

No. This document describes a new reagent for quantitative chemical analysis, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.

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

The entire study described is a standalone performance study of the ATAC PAK Phosphorus Reagent Kit on the ATAC 8000 Random Access Chemistry System. It assesses the analytical performance of the reagent (linearity, precision, method comparison, detection limit, stability) without human intervention in the result generation itself, beyond standard laboratory practices for sample handling and system operation. There is no human-in-the-loop component described for the device's performance.

7. The type of ground truth used

• Linearity: Based on "standard values" from "linearity standards that span the usable range." These standards would have known, certified phosphorus concentrations.
• Precision: Based on "commercially available control serum" which have established target values and acceptable ranges.
• Method Comparison: The "competitive reagent" (predicate device) serves as the "ground truth" or reference for comparison. The assumption is that the predicate device is accurate and provides clinically acceptable results.
• Detection Limit: Derived from the statistical analysis of repetitive assays of a "diluted serum pool."
• Stability: Assessed against the initial, presumably accurate, values of "serum controls" over time.

In summary, the ground truth is primarily based on reference materials, certified controls, and comparison to an established predicate device.

8. The sample size for the training set

Not applicable. This device is an in vitro diagnostic reagent, not an AI or machine learning algorithm that requires a "training set." Its performance is based on chemical reactions and photometric measurements, validated through analytical studies.

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 PAK Albumin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The ATAC PAK Albumin Reagent determines albumin by the selective binding of bromcresol green. The resulting increase in absorbance at 630 nm is proportional to the albumin concentration in the sample.

The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. The study presented demonstrates its substantial equivalence to the Roche Albumin Reagent Kit (product no. 1970569).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Linearity/Recovery: n = 33 (implied by the regression statistics, corresponding to pairs of ATAC recoveries vs. Reference Values). The data provenance is not explicitly stated but implies laboratory-prepared linearity standards.
• Precision:
  • Serum 1: n = 60 replicates
  • Serum 2: n = 60 replicates
  • Serum 3: n = 60 replicates
  • The samples used are "commercially available control serum." The country of origin is not specified, and the study is prospective in nature for determining precision.
• Method Comparison: n = 119 for mixed serum and plasma specimens. These were "collected from adult patients," suggesting a prospective collection of clinical samples. The country of origin is not specified.
• Detection Limit: n = 30 replicates of a diluted serum pool. This is a prospective study.
• Stability Studies: "serum controls" were assayed. Specific sample sizes for controls are not given, but the study is prospective.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This device is a diagnostic reagent kit, and the "ground truth" for its performance is established through analytical validation studies using reference methods, standards, and control materials, rather than expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method

• Not applicable. As described above, the studies involve analytical measurements against established reference values or comparative measurements with a predicate device, not subjective interpretation requiring expert adjudication.

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

• No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically performed for medical imaging devices where human interpretation is a critical component of the diagnostic process. This submission pertains to an in-vitro diagnostic reagent kit for quantitative biochemical measurement.

6. Standalone Performance Study

• Yes, a standalone (algorithm only) performance study was done for the ATAC PAK Albumin Reagent Kit. The studies presented (linearity, precision, method comparison, detection limit, stability) directly assess the performance of the reagent kit when run on the ATAC 8000 Random Access Chemistry System, without human interpretive input affecting the core measurement.

7. Type of Ground Truth Used

The ground truth for the performance studies was established through:

• Reference Values: For linearity, values are compared against "Reference Value" standards.
• Commercial Control Serum: For precision, commercially available control sera with assigned values (mean, 1SD, %CV) serve as the reference.
• Predicate Device/Commercially Available Method: For method comparison, the results from the ATAC PAK Albumin Reagent Kit are compared against results from an "another commercially available method" (the predicate device).
• Established Analytical Principles: For detection limit, it's based on the statistical calculation from repetitive assays of a diluted serum pool.

8. Sample Size for the Training Set

• Not applicable. This device is an in-vitro diagnostic reagent kit, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on chemical reactions and photometric measurements. The manufacturing process and quality control would be validated, but there isn't a "training set" for the reagent itself.

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

• Not applicable, as there is no training set for this 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.

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

• Linearity Study: n = 27 (number of standard recoveries used for regression).
• Precision Study: n = 120 for each of the 5 samples (3 serum controls, 2 urine pools). It's explicitly stated as "replicate assay," implying prospective measurement of specific control materials.
• Method Comparison (Serum/Plasma): n = 200 mixed serum/plasma specimens from adult patients. The data is prospective, collected by assaying specimens using both the ATAC 8000 and another commercial method. The origin is not explicitly stated, but given the company's US address, it's likely US-based, though not definitively provided.
• Method Comparison (Urine): n = 96 diluted urine specimens from adult patients. Prospective data, similar to the serum/plasma comparison, with likely US origin.
• Stability Studies: Not explicitly stated, but involved assaying "serum controls and urine pools over the claimed periods."

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

This information is not applicable to this type of device and study. The "ground truth" for creatinine measurement is established by the analytical method itself, often through internal calibrators traceable to a reference standard (though not explicitly stated for this kit, it's standard practice). The comparison is against another commercially available, validated method. There are no human experts "establishing ground truth" in the diagnostic interpretation sense for a biochemical reagent kit.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication processes (like 2+1, 3+1) are used in studies where human interpretation of data (e.g., images, clinical findings) is involved and a consensus "ground truth" needs to be established. 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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices or other interpretation-based devices where human readers assess cases. This document describes the analytical performance of a reagent kit.

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

Yes, the studies described are standalone performance evaluations of the ATAC PAK Creatinine Reagent Kit used on the ATAC 8000 Random Access Chemistry System. These are "algorithm only" in the sense that they evaluate the analytical performance of the chemical reaction and the instrument's measurement capabilities, not involving human interpretation or decision-making as a primary performance metric beyond standard laboratory practices.

7. The Type of Ground Truth Used

• Linearity: The "ground truth" was established by standard values (known concentrations of creatinine standards).
• Precision: The "ground truth" was the mean concentration determined for commercially available control serum and urine pools.
• Method Comparison: The "ground truth" for comparison was the measurements obtained from an established, commercially available reference method (the "Competitive Reagent"). This is a form of comparative ground truth, where the new method is validated against an accepted one.

8. The Sample Size for the Training Set

This information is not explicitly provided in the document. For chemical reagent kits, there isn't typically a "training set" in the machine learning sense. Instead, development and optimization would involve numerous studies (assay development, formulation testing, preliminary performance runs) leading to the final reagent formulation and instrument protocol, but these aren't usually presented as a distinct "training set" in regulatory submissions. The studies presented are validation studies.

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

As there isn't a "training set" as understood in machine learning contexts for this type of device, this question is not applicable. The "ground truth" for developing a chemical assay is built upon fundamental chemical principles, analytical accuracy provided by known standards, and optimization processes to ensure proper reaction kinetics and measurement properties.

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The ATAC PAK BUN Reagent Kit is intended for the quantitative determination of urea nitrogen in serum, plasma and urine. Urea nitrogen results are used in the diagnosis and treatment of certain renal and metabolic diseases.

The ATAC PAK BUN Reagent determines urea nitrogen through the enzymatic action of urease and glutamate delydrogenase. The resulting decrease in absorbance at 340 nm is proportional to the urea nitrogen concentration of the sample.

This document focuses on the ATAC PAK BUN Reagent Kit, an in-vitro diagnostic device designed for the quantitative determination of urea nitrogen. The provided text describes the device's performance characteristics and how they demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity/Recovery: n = 50 (for regression statistics comparing standard values).
• Precision:
  • Serum 1: n = 60
  • Serum 2: n = 60
  • Serum 3: n = 60
  • Urine 1: n = 60
  • Urine 2: n = 60
    (Precision studies used commercially available control serum and urine pools.)
• Method Comparison (Serum/Plasma): n = 217.
• Method Comparison (Urine): n = 92.
• Detection Limit: 30 replicates of a diluted serum control.

Data Provenance: The document states that mixed serum, plasma, and diluted urine specimens were "collected from adult patients." It also mentions "commercially available control serum." The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the data would comply with U.S. regulatory standards. The studies appear to be prospective as they were conducted to demonstrate the performance of the ATAC PAK BUN Reagent Kit.

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

This type of in-vitro diagnostic (IVD) device study does not typically involve "experts" establishing a ground truth in the way medical imaging or clinical diagnosis studies do. For IVDs, the "ground truth" is established through:

• Reference materials: For linearity, known standard values are used.
• Established analytical methods: For method comparison, a "competitive commercially available method" is used as a reference.
• Control materials: For precision, commercially available control serum and urine pools with known target ranges are used.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is based on reference standards, established methods, and control materials, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. This is an in-vitro diagnostic device, not an imaging or diagnostic device that relies on human interpretation of complex data. The study focuses on the analytical performance of the reagent kit itself.

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

Yes, the studies described are standalone performance evaluations of the ATAC PAK BUN Reagent Kit on the ATAC 8000 Random Access Chemistry System. These are analytical performance studies of the device itself, without human intervention in the result determination process beyond standard laboratory operating procedures.

7. The Type of Ground Truth Used

• Linearity: Known standard values/concentrations.
• Precision: Commercially available control serum and urine pools with established target ranges.
• Method Comparison: Results from a "commercially available method" (i.e., another established and validated BUN assay). This serves as the comparative reference.
• Detection Limit: Diluted serum control with a known low concentration.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models, as this is an in-vitro diagnostic reagent kit, not an AI-powered device. The studies described are performance validation studies.

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

As there is no explicit "training set" in the AI/machine learning sense, this question is not directly applicable. The performance characteristics are demonstrated using the previously described methods (reference materials, control materials, comparative methods).

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The ATAC Direct LDL Reagent Kit, the ATAC Direct LDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for the quantitative determination of LDL-cholesterol in serum and plasma. LDL-cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

The ATAC Direct LDL Reagent determines LDL-cholesterol through a two step reaction, which specifically consumes non-LDL cholesterol in a series of reactions without producing color. In the second reaction step, the chromogen is added, and a second detergent solubilizes the LDL-cholesterol, allowing it to react with cholesterol oxidase, cholesterol esterase and peroxidase in the reagent to produce a color that is proportional to the amount of LDL-cholesterol in the sample.

Here's a breakdown of the acceptance criteria and the study details for the ATAC Direct LDL Reagent Kit, ATAC Direct LDL Calibrator, and ATAC 8000 Random Access Chemistry System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Linearity Study: n = 35 (number of standard factors, implicitly indicating the number of samples used to establish linearity)
• Precision Study:
  • Serum 1: n = 60
  • Serum 2: n = 60
  • Serum 3: n = 59
• Comparison to Competitive Reagent: n = 159 (mixed serum and plasma specimens from adult patients)
• Accuracy (Comparison to Beta-Quantification Reference Method): n = 42 (serum and plasma specimens from 22 adults)
• Detection Limit Study: 30 replicates of a diluted serum pool.

Data Provenance: The text states, "Mixed serum and plasma specimens, collected from adult patients," and "42 serum and plasma specimens, collected from 22 adults." This indicates the data is from human patients. While the specific country of origin is not explicitly stated, the submission is to the US FDA, implying testing relevant to that regulatory body, likely involving US-based studies. The studies are prospective in nature, as they involve performing assays to determine the device's performance.

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

This device is an in vitro diagnostic for measuring a chemical analyte (LDL-cholesterol). The "ground truth" is established by standard laboratory reference methods or highly-regarded comparative methods, not by expert interpretation of images or other subjective assessments.

• For "Accuracy" studies: The ground truth was established by the beta-quantification reference method.
• For "Comparison" studies: The ground truth was established by a "commercially available method" (another LDL-cholesterol assay).

Therefore, there were no human "experts" in the sense of clinicians or radiologists establishing ground truth. The "experts" are the established and validated laboratory methodologies.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to form a ground truth. Here, the ground truth is determined by objective chemical or reference methods.

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

No. An MRMC study is not relevant for this type of in vitro diagnostic device. This device measures an analyte; it's not an imaging or diagnostic tool where human readers interpret outputs.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the studies directly assess the "standalone" performance of the ATAC Direct LDL Reagent Kit and the ATAC Direct LDL Calibrator used on the ATAC 8000 Random Access Chemistry System. The reported performance metrics (linearity, precision, correlation, accuracy, detection limit, stability) are all measurements of the device's inherent capability, without human intervention in the analytical measurement process itself. The "human-in-the-loop" would be the laboratory personnel operating the system and interpreting the quantitative numerical results, but the performance data presented here are for the device alone.

7. Type of Ground Truth Used

The ground truth used in the studies includes:

• Reference Method: Beta-quantification method (for accuracy assessment). This is a highly accurate and established method for measuring LDL-C.
• Comparative Commercial Method: Another commercially available LDL-cholesterol assay (for method comparison).
• Standard Factors: Pre-defined concentrations of LDL-cholesterol (for linearity assessment).
• Commercially Available Control Serum / Serum Pool: Materials with known or expected LDL-C values (for precision assessment).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a chemical reagent and an automated chemistry analyzer, not an AI/ML algorithm that requires training data in the typical sense. It relies on chemical reactions and photometric detection calibrated against known standards.

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

As there is no "training set" in the AI/ML sense for this type of device, this question is not applicable. The device's operational parameters and calibration are established using defined standards and controls, as outlined in the linearity and stability studies, which serve a similar function to "training" in ensuring the device performs correctly.

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