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The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCG2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Albumin BCG2 assay is an automated clinical chemistry assay. The Albumin BCG2 procedure is based on the binding of bromocresol green in the assay reagent specifically with albumin in the patient sample to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.

Methodology: Colorimetric (Bromocresol Green)

The device in question is the Albumin BCG2 assay, used for the quantitation of albumin in human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Within-Laboratory Precision: For each of the 2 controls and 3 human serum panels, 80 replicates were tested (2 duplicates per day for 20 days). The provenance of the human serum panels is not specified (e.g., country of origin, retrospective or prospective).
• Accuracy: The sample size for the accuracy study is not specified, but it involved determining bias relative to a standard reference material.
• Lower Limits of Measurement: For LoB, LoD, and LoQ, n ≥ 60 replicates of zero-analyte (LoB) or low-analyte (LoD, LoQ) samples were used.
• Linearity: The sample size for the linearity study is not explicitly stated.
• Potentially Interfering Substances: The sample size for this study is not explicitly stated.
• Method Comparison: 128 serum samples were used. The provenance of these samples is not specified.
• Tube Type: Samples were collected from a minimum of 40 donors. The provenance of these samples is not specified.

The studies described are non-clinical laboratory studies, suggesting they were conducted in a controlled lab setting rather than directly on patient data in a clinical environment. Whether the data is retrospective or prospective is not explicitly stated, but the nature of the studies (e.g., precision, linearity) typically involves prospective experimental designs.

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

This information is not applicable to the Albumin BCG2 assay studies described. This device is an in vitro diagnostic (IVD) quantitative assay, and its performance is evaluated against analytical benchmarks, reference materials, or a predicate device, not by expert interpretation of images or clinical outcomes that require a ground truth established by human experts.

4. Adjudication Method

Not applicable for this type of IVD device and studies. Performance is measured using quantitative analytical methods, not involving human adjudication of results.

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

Not applicable. This is a quantitative laboratory assay, not an imaging device or AI-assisted diagnostic tool that would involve human readers or MRMC studies.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies of the Albumin BCG2 assay. The results reflect the algorithm/device's analytical performance (precision, accuracy, linearity, etc.) without human intervention in the result generation or interpretation to arrive at the reported quantitative values. The "human-in-the-loop" for this type of device typically refers to standard laboratory procedures for running samples and interpreting flagged results, which is inherent to its use but not a part of the core performance metrics discussed here.

7. Type of Ground Truth Used

• Accuracy: The ground truth for accuracy was established using a standard reference material: European Reference Materials Standard Reference Material - DA470k/ International Federation of Clinical Chemistry and Laboratory Medicine (ERM - DA470k/IFCC).
• Method Comparison: The predicate device, Albumin BCG (K981758; List No. 7D53), served as the reference for comparison, effectively acting as a "ground truth" or established method against which the new device's measurements were assessed for agreement.
• For other analytical performance characteristics (precision, linearity, limits of measurement, interference), the "ground truth" is understood as the expected or known concentrations in spiked samples, controls, or reference materials, or ideal analytical behavior.

8. Sample Size for the Training Set

Not applicable. This document describes a traditional in vitro diagnostic device, not one utilizing machine learning or artificial intelligence that would typically involve a "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for this device.

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Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.

Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.

The provided text describes the performance of several Medicon Hellas assays (Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen) when run on the Diatron Pictus 500 Clinical Chemistry Analyzer, demonstrating their substantial equivalence to predicate devices (Beckman Coulter AU reagents on AU2700 analyzer, and Abbott Architect Direct Bilirubin on Architect c8000 analyzer).

Here's an analysis of the provided information, structured to address your specific points regarding acceptance criteria and study details:

1. A Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a single, overarching table with pass/fail remarks. Instead, it describes each performance characteristic and then presents the results. The "Summary" sections for each study type imply that the results met the pre-defined acceptance criteria for demonstrating substantial equivalence. For instance, for accuracy, it states "Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin... are substantially equivalent to the related predicate devices." This implies that the statistical analyses (Deming regression, R2, slope, intercept) fell within acceptable ranges. Similarly, for precision, it states "All lots passed acceptance criteria for each applicable sample type at each level."

Since explicit acceptance criteria are not presented, they are inferred from the demonstrated performance and the statement that the devices "passed acceptance criteria" or "met statistical acceptance criteria." Below is a table summarizing the reported device performance for each analyte. The "Acceptance Criteria" column will reflect the general statements of success or the implied ranges from the results themselves, as explicit numerical targets for individual tests are not given.

Implied Acceptance Criteria and Reported Device Performance

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For in vitro diagnostic use only

The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.

The ALB test is a multilayered, analytical element coated on a polyester support.

For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.

The provided document describes the analytical performance of the VITROS XT Chemistry Products ALB-TP Slides for measuring albumin (ALB) concentration, and its substantial equivalence to a predicate device.

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

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

The document does not explicitly state formal "acceptance criteria" for each performance metric in a dedicated table. Instead, performance is demonstrated through studies and compared against established clinical laboratory guidelines (CLSI protocols) or by showing strong correlation to the predicate device. For some metrics, an implied acceptance based on clinical relevance and comparison to the predicate can be inferred.

Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the context of the studies:

• N: 127
• Slope: 1.00
• Intercept: -0.03
• Correlation Coeff.: 0.999
• Test Range: 1.0 - 5.9
• Measuring Range: 1.0 - 6.0 |
  | Matrix Comparison | Acceptable performance across different sample types (serum, plasma) compared to a reference serum type (red top plastic serum tube), with slopes near 1 and intercepts near 0, demonstrating equivalence. | Regression results vs. Serum Plastic:
• Na Hep: Slope 0.96, Intercept 0.098
• Li Hep: Slope 0.96, Intercept 0.088
• PST: Slope 0.95, Intercept 0.107
• SST: Slope 0.99, Intercept 0.033
• Serum Glass: Slope 1.00, Intercept -0.007 |
  | Precision | Meets performance guidelines for precision (e.g., CLSI EP05-A3), demonstrating low variability (low SD and %CV) across different concentrations and over time (repeatability, within-day, within-lab). Specific criteria for SD/CV are not explicitly given but are generally expected to be within clinically acceptable limits. | Representative Lot Precision (g/dL Albumin):
• Mean Conc. 1.6: Repeatability %CV 1.2, Within Lab %CV 1.4
• Mean Conc. 2.7: Repeatability %CV 0.9, Within Lab %CV 1.2
• Mean Conc. 3.4: Repeatability %CV 0.8, Within Lab %CV 1.1
• Mean Conc. 4.1: Repeatability %CV 1.0, Within Lab %CV 1.3
• Mean Conc. 4.4: Repeatability %CV 0.7, Within Lab %CV 0.9
• Mean Conc. 5.2: Repeatability %CV 0.9, Within Lab %CV 1.2 |
  | Detection Limits (LoQ)| LoQ determined based on pre-defined Total Error (TE) goals, with a specific goal of ≤ 0.2 g/dL. | ALB (g/dL):
• LOB: 0.24
• LOD: 0.27
• LOQ: 0.60
• Claimed LOQ: 1.0 (This implies the device achieves a tighter LoQ than the claimed range allows) |
  | Linearity | Supports the claimed measuring range (1.0 - 6.0 g/dL), demonstrated by a linear response across a wider range (e.g., 0.5 - 7.1 g/dL) with a high correlation (R close to 1) and appropriate slope/intercept. Follows CLSI EP06-A. | ALB:
• Measuring Range: 1.0 - 6.0 g/dL
• Linear Range: 0.5 - 7.1 g/dL
• Least Squares Regression: y = 1.01x - 0.19 with R = 1.00 |
  | Specificity (Interference) | Bias -0.38; 4 g/dL (4.8 g/dL ALB) -> -0.58
• Hemoglobin: 300 mg/dL (3.8 g/dL ALB) -> 0.32; 200 mg/dL (4.6 g/dL ALB) -> 0.37
  47 test substances found not to interfere (bias

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BA400: The BA400 analyser is used to determine analyte concentrations by in vitro biochemical and turbidimetric measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood. This device is intended to replace manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity.

ALBUMIN: Reagent for the measurement of albumin concentration in human serum or plasma. The obtained values are useful as an aid in the evaluation of protein synthesis of the liver in the chronic liver diseases and for the nutritional status. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

ALKALINE PHOSPHATASE (ALP) - AMP: Reagent for the measurement of alkaline phosphatase (ALP)-AMP concentration in human serum or plasma. The obtained values are useful as an aid in the diagnosis and treatment of hepatobiliary and bone diseases with impaired osteoblastic activity diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

GLUCOSE-HEXOKINASE: Reagent for the measurement of glucose concentration in human serum, plasma, urine or cerebrospinal fluid. The obtained values are useful as an aid in the diagnosis and monitoring of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for several in vitro diagnostic reagents and an analyzer. It only provides information about the intended use of the devices and their regulatory classification. It does not contain any data, studies, acceptance criteria, or performance results for the devices mentioned (ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE reagents, or the BA400 analyzer).

Therefore, I cannot provide the requested information in the requested format because the input document does not contain it.

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ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum and lithium heparin plasma using the ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex, which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.

Here's an analysis of the acceptance criteria and study information for the ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state formal "acceptance criteria" with specific thresholds for each performance metric. However, it presents detailed performance data, particularly precision (within-run and total %CV) and method comparison (regression analysis, correlation coefficient), comparing the new reagents on various ACE clinical chemistry systems (ACE, ACE Alera, ACE Axcel) against existing predicate devices and among themselves. The implied acceptance is that the new reagents perform comparably to, or as effectively as, the predicate devices and demonstrate acceptable precision and linearity for clinical use.

Below is a summary of the reported device performance based on the "In-House Precision" and "In-House Matrix Comparison" tables. Since explicit acceptance criteria are not given, the performance data itself is presented as the evidence of meeting implied clinical utility and equivalence to predicate devices.

ACE Albumin Reagent

ACE Total Protein Reagent

ACE Calcium-Arsenazo Reagent

ACE Inorganic Phosphorus U.V. Reagent

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

The studies mentioned are "In-House Precision," "In-House Matrix Comparison: Serum vs. Plasma," "POL - Precision," and "POL – Method Comparison."

• In-House Precision (Serum vs. Plasma):
  • Sample Size: Not explicitly stated for each "low, mid, high" concentration level, but implies multiple replicates for each level tested across the three systems (ACE, Alera, Axcel). For example, the ACE Alera precision table (pg. 16) shows 3 levels (low, mid, high) for serum, with reported mean, within-run SD, and total SD. Typically, precision studies involve running samples multiple times a day over several days.
  • Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. It is a prospective study as they are performing experiments to generate data.
• In-House Matrix Comparison: Serum vs. Plasma:
  • Sample Size:
    • Albumin: ACE: 55 pairs, ACE Alera: 56 pairs, ACE Axcel: 56 pairs
    • Total Protein: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
    • Calcium-Arsenazo: ACE: 56 pairs, ACE Alera: 56 pairs, ACE Axcel: 81 pairs
    • Inorganic Phosphorus: ACE: 100 pairs, ACE Alera: 102 pairs, ACE Axcel: 56 pairs
  • Data Provenance: "In-House" suggests it was conducted by Alfa Wassermann Diagnostic Technologies, LLC, likely at their own facilities. The comparison between serum and plasma samples implies these were collected from human subjects. This is a prospective study.
• POL (Physician Office Laboratory) - Precision:
  • Sample Size: For each reagent and each system (ACE and ACE Alera), there are 3 "samples" (representing different concentration levels) tested at 3 different POL sites. Each sample/site combination has "Within-Run" and "Total" precision reported, implying multiple replicates for each measurement.
  • Data Provenance: Conducted at "POL 1," "POL 2," and "POL 3" sites, indicating external collection and testing beyond the manufacturer's immediate facilities. This is a prospective study.
• POL (Physician Office Laboratory) - Method Comparison:
  • Sample Size:
    • Albumin: 50 samples for each POL site (x3 POLs)
    • Total Protein: 51 samples for each POL site (x3 POLs)
    • Calcium-Arsenazo: 50 samples for each POL site (x3 POLs)
    • Inorganic Phosphorus: 50 samples for POL 1 & 3, 48 samples for POL 2
  • Data Provenance: Comparisons between "ACE In-House (x)" and "ACE POL (y)" or "ACE In-House (x)" and "ACE Alera POL (y)". This indicates the data for these studies was collected at both in-house facilities and external Physician Office Laboratories. This is a prospective study design, comparing results from different testing environments.
• Detection Limits & Linearity (ACE Alera):
  • Sample Size: Not specified for these specific studies, but typically involves a series of diluted and concentrated samples to define the measuring range.
  • Data Provenance: In-House, prospective.
• Interference (ACE Alera):
  • Sample Size: Not specified, but involves spiking samples with various interferents at different concentrations.
  • Data Provenance: In-House, prospective.

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

For these types of in vitro diagnostic (IVD) assays, the "ground truth" is typically established by reference methods or validated comparative methods, often using certified calibrators and controls. The documentation does not mention the use of human experts to establish ground truth for the test set in the traditional sense of medical image interpretation (e.g., radiologists interpreting images). Instead, the studies rely on quantitative measurements and statistical comparisons with established methods (the predicate devices or in-house reference measurements) to demonstrate performance. Therefore, no information is provided on the number or qualifications of experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the "ground truth" for these quantitative chemical assays is not established through expert consensus or adjudication in the way it would be for qualitative or interpretive diagnostic devices like medical imaging. Performance is evaluated by statistical comparison of numerical 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

Not applicable. This device consists of chemical reagents for laboratory measurement, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this submission.

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

The performance presented for these reagents is inherently "standalone" in the sense that it reflects the direct analytical performance of the assays on the specified automated clinical chemistry systems. The results are quantitative measurements produced by the device without human interpretation of raw data beyond reading the numerical output. The "without human-in-the-loop" aspect applies here as the device itself performs the measurement and outputs a numerical value of concentration. The method comparison studies demonstrate the standalone performance of the candidate devices compared to predicate devices.

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

The ground truth for these assays is established through reference methods and comparison to legally marketed predicate devices.

• For precision, the "ground truth" for each replicate is assumed to be the true concentration within the sample, and the study assesses the reproducibility of the device in measuring that concentration.
• For method comparison studies (e.g., In-House vs. POL, or ACE vs. ACE Alera), one method's results (often the predicate or an established in-house method) serve as the comparative 'truth' to evaluate the new method's agreement. The reference method would itself be calibrated against known standards.
• For linearity, samples of known, graded concentrations are used.
• For detection limits, the ground truth involves samples with very low, known concentrations.

These are established analytical chemistry principles rather than "expert consensus" or "pathology" in the diagnostic interpretation sense.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning or AI algorithms which are iteratively developed and optimized using data. These reagents are chemical assays with a defined photometric measurement principle. While there is a development phase that involves optimizing reagent formulations and instrument parameters, there isn't a "training set" in the computational sense. The data presented here are from formal "verification and validation studies" to demonstrate performance characteristics (precision, linearity, accuracy/comparison, interference, detection limits).

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

As noted in point 8, the concept of a "training set" is not directly applicable to these chemical reagents. The "ground truth" for establishing and validating the performance of such assays is based on:

• Reference materials/calibrators: Solutions with precisely known concentrations of the analyte (albumin, total protein, calcium, phosphorus) traceable to international standards.
• Validated comparison methods: Measurements made by existing, legally marketed predicate devices or other well-established and accurate laboratory methods.
• Controlled spiking experiments: Adding known amounts of substance to samples to assess recovery, linearity, and interference.

These methods establish the quantitative "truth" against which the performance of the new reagents is measured.

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The ACE Albumin Reagent is intended for the quantitative determination of albumin concentration in serum using the ACE Axcel Clinical Chemistry System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Protein Reagent is intended for the quantitative determination of total protein concentration in serum using the ACE Axcel Clinical Chemistry System. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Calcium-Arsenazo Reagent is intended for the quantitative determination of calcium concentration in serum using the ACE Axcel Clinical Chemistry System. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Inorganic Phosphorus U.V. Reagent is intended for the quantitative determination of inorganic phosphorus concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of inorganic phosphorus are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

In the ACE Albumin Reagent assay, Bromcresol green binds specifically to albumin to form a green colored complex, which is measured bichromatically at 629 nm/692 nm. The intensity of color produced is directly proportional to the albumin concentration in the sample.

In the ACE Total Protein Reagent assay, cupric ions react with the peptide bonds of proteins under alkaline conditions to form a violet colored complex which is measured bichromatically at 544 nm/692 nm. The intensity of color produced is directly proportional to the total protein concentration in the sample.

In the ACE Calcium-Arsenazo Reagent assay, calcium reacts with Arsenazo III in an acidic solution to form a blue-purple colored complex, which is measured bichromatically at 647 nm/692 nm. The intensity of color produced is directly proportional to the calcium concentration in the sample.

In the ACE Inorganic Phosphorus U.V. Reagent assay, under acidic conditions, inorganic phosphorus in serum reacts with ammonium molybdate to form an unreduced phosphomolybdate complex, which absorbs strongly at 340 nm. The increase in absorbance, measured bichromatically at 340 nm/378 nm, is directly proportional to the amount of phosphorus in the sample.

The ACE Albumin Reagent consists of a single reagent bottle. The reagent contains Bromcresol green and acetate buffer.

The ACE Total Protein Reagent consists of a single reagent bottle. The reagent contains copper sulfate, sodium potassium tartrate, potassium iodide and sodium hydroxide.

The ACE Calcium-Arsenazo Reagent consists of a single reagent bottle. The Reagent contains Arsenazo III.

The ACE Inorganic Phosphorus U.V. Reagent consists of a single reagent bottle. The reagent contains ammonium molybdate and sulfuric acid.

Acceptance Criteria and Device Performance Study for ACE Reagents

The provided 510(k) summary (K113374) describes the performance of four reagents: ACE Albumin Reagent, ACE Total Protein Reagent, ACE Calcium-Arsenazo Reagent, and ACE Inorganic Phosphorus U.V. Reagent, when used with the Alfa Wassermann ACE Axcel Clinical Chemistry System. The study establishes the substantial equivalence of these devices to their predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms (e.g., "CV must be

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The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Not Found

This document is a 510(k) clearance letter for an in vitro diagnostic device, the Poly-Chem 90 Albumin, BUN, Calcium, Carbon Dioxide, and Creatinine tests. It is not a study report or clinical trial document. Therefore, it does not contain the specific information requested about acceptance criteria, device performance, study design, or ground truth establishment.

A 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on a new clinical study with acceptance criteria and performance metrics described in detail within the clearance letter itself. The types of studies referenced in your request (e.g., sample size for test set, expert involvement, MRMC studies, standalone performance) are more common for novel or higher-risk devices that require a PMA (Premarket Approval) or for performance studies conducted by the manufacturer that are submitted as part of the 510(k) but not fully detailed in the FDA's clearance summary.

Therefore, I cannot provide the requested information from the provided text. The document primarily confirms that the FDA has reviewed the manufacturer's submission and found the device substantially equivalent to existing devices, allowing it to be marketed.

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ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.

The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid].

The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.

ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.

The provided text describes several in-vitro diagnostic devices (reagents, calibrators, and controls) and their performance characteristics. However, it does not contain information about studies involving AI, human readers, or image analysis. The data provided is for traditional laboratory assays, comparing a new device to a predicate device.

Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable or cannot be extracted from this document, such as:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not specified for clinical samples in the context of an AI study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts - Not applicable for chemical assays.
• Adjudication method - Not applicable for chemical assays.
• 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 AI component described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - No AI component described.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Not explicitly stated in terms of expert consensus or pathology for clinical samples, but implied to be analytical results from established methods.
• The sample size for the training set - No AI component described, so no training set discussed.
• How the ground truth for the training set was established - No AI component described.

Below is an attempt to address the request based only on the information available in the provided text, primarily focusing on the "ELITech Clinical Systems CALCIUM ARSENAZO" reagent as it is the first device detailed.

Acceptance Criteria and Device Performance Study for ELITech Clinical Systems CALCIUM ARSENAZO

The provided document describes the performance characteristics of the ELITech Clinical Systems CALCIUM ARSENAZO reagent, a quantitative in vitro diagnostic device for total calcium in human serum and plasma. The study presented is a comparison to a legally marketed predicate device, Stanbio Calcium LiquiColor® (Arsenazo III) (K921625), to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, where the new device's performance metrics are expected to be comparable or better. The table below summarizes the reported performance of the ELITech Clinical Systems CALCIUM ARSENAZO. Specific numerical acceptance criteria (e.g., "must be ≥X") are not explicitly stated as separate targets, but rather demonstrated through direct comparison to the predicate's known performance or through established analytical performance ranges.

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

The document does not explicitly state the specific sample size for the clinical test set used in method comparison or interference studies. It is described as testing human serum and plasma.
The data provenance (country of origin, retrospective/prospective) is not specified in this summary.

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

Not applicable. This is a chemical assay, not an assessment requiring expert interpretation of images or clinical findings. The "ground truth" for the test set would be established by the predicate device's accepted analytical results, or other reference methods for analytical performance studies.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human adjudication of clinical findings.

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 document describes an in vitro diagnostic reagent; there is no AI component or human reader study involved.

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

Not applicable. This document describes an in vitro diagnostic reagent; there is no algorithm or AI component. The "standalone" performance here refers to the analytical performance of the reagent on the specified analyzer.

7. The Type of Ground Truth Used

For method comparison, the ground truth is established by comparing the results of the ELITech Clinical Systems CALCIUM ARSENAZO with analyses performed using the predicate device (Stanbio Calcium LiquiColor®) on the same samples. For precision, linearity, and interference studies, ground truth would be based on known concentrations or preparations in control materials and spiked samples. This is a form of analytical ground truth.

8. The Sample Size for the Training Set

Not applicable. There is no AI component, and thus no "training set" in the context of machine learning.

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

Not applicable as there is no training set for an AI model. For the analytical studies, ground truth is established through standard laboratory practices for calibrators, controls, and comparative methods.

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The EasyRA albumin reagent is intended for the quantitative determination of Albumin (ALB) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. For in vitro diagnostic use only.

The EasyRA total calcium reagent is intended for the quantitative measurement of Total Calcium (Ca) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety if bone diseases, chronic renal disease and tetany. For in vitro diagnostic use only.

The EasyRA magnesium reagent is intended for the quantitative measurement of Magnesium (Mg) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.

This reagent is intended for the quantitative measurement of Inorganic Phosphorous (PHOS) in human serum and plasma. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance.

Not Found

This document is a 510(k) clearance letter for in vitro diagnostic reagents, not a study describing the performance of an AI-powered medical device. As such, most of the requested information (acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.

The document discusses the regulatory clearance of "EasyRA Albumin Reagent, EasyRA Calcium Reagent, Easy RA Magnesium Reagent, Easy RA Inorganic Phosphorus Reagent" for use with the MEDICA "EasyRA Chemistry Analyzer" for quantitative determination of various substances in human serum and plasma.

Therefore, I cannot provide a table of acceptance criteria, device performance, study details, or information related to AI performance from this document.

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The EasyRA Albumin (ALB) reagent is intended for the quantitative determination of Albumin in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The EasyRA Alkaline Phosphatase (ALP) reagent is intended for the quantitative determination of Alkaline Phosphatase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Alkaline Phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.

The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Aspartate Aminotranferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The EasyRA Carbon Dioxide (CO2) reagent is intended for the quantitative measurement of Carbon Dioxide (CO2) in human serum, Bicarbonate/carbon dioxide measurements arc used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Carbon Dioxide calibrator establishes points of reference that are used in the determination of values in the measurement of Bicarbonate/Carbon dioxide on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's CO2 reagent.

The EasyRA CREA reagent is a device intended to measure creatinine levels in serum. Creatinine measurements 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 EasyRA CK reagent is a device intended to measure creatinine kinase activity in serum. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for various EasyRA reagents (Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Carbon Dioxide, Creatinine, Creatine Kinase) and a Carbon Dioxide Calibrator.

The document primarily states that the FDA has determined these devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed. It lists the indications for use for each reagent but does not detail any performance studies, acceptance criteria, or specific data from such studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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