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The Atellica® CH Diazo Direct Bilirubin (D DBil) assay is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma using the Atellica® CH Analyzer. Measurement of direct bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic-hematological, and metabolic disorders, including hepatitis and gall bladder block.

Atellica® CH Diazo Direct Bilirubin is a Photometric test using 2,4-dichloroaniline (DCA). Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a red colored azocompound in acidic solution. Absorbance is measured at 545/658 nm.

The provided text describes the performance characteristics and acceptance criteria for the Atellica® CH Diazo Direct Bilirubin (D DBil) assay. Here's a breakdown of the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Note: Specific acceptance criteria for precision and reproducibility are not explicitly listed as single values but are implied by the comprehensive presentation of the data, demonstrating acceptable variability for a diagnostic assay. The document states that the results "support that the Candidate Device... is substantially equivalent."

2. Sample size used for the test set and the data provenance:

• Assay Comparison: N = 100 samples
• Specimen Equivalency (Plasma vs. Serum): N = 53 samples for each plasma type (Lithium heparin, Sodium heparin, K2(EDTA)).
• Precision: N = 80 for each serum level (4 serum levels tested, total 320 measurements).
• Reproducibility: N = 225 for each serum level (4 serum levels tested, total 900 measurements).
• Interferences (HIL and Non-interfering Substances): The number of samples for interference testing is not explicitly stated as a single 'N' for the test set. However, the tables indicate specific analyte concentrations tested (e.g., for Hemoglobin, Lipemia, Acetaminophen, etc.), implying multiple measurements were performed for each interference level.

Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective.

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

This information is not applicable as the device is an in vitro diagnostic assay for quantitative determination of direct bilirubin. The "ground truth" in this context refers to the measured concentration of direct bilirubin, which is established by established laboratory methods, standard reference materials, and comparison to a predicate device, rather than expert interpretation of images or clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical imaging interpretation) where multiple readers assess cases and discrepancies are resolved by a super-reader. For a quantitative diagnostic assay, the "ground truth" is determined by objective measurement rather than expert consensus on subjective 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:

This information is not applicable. The device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this submission.

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

The device is a standalone in vitro diagnostic assay. Its performance is measured independently of human interpretation in the clinical setting, although laboratory personnel operate the analyzer and interpret the numerical results in the context of a patient's overall clinical picture. The studies described (Precision, Reproducibility, Assay Comparison, Specimen Equivalency, Interferences) all reflect the standalone performance of the assay on the Atellica CH Analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance studies is established by:

• Reference Methods/Predicate Device: The "Assay Comparison" section uses the Wako Direct Bilirubin V assay as the comparative method.
• Internal Reference Standards: The assay's traceability is to internal reference standards manufactured by gravimetric methods.
• Control Samples/Spiking: For precision, reproducibility, and interference studies, samples are prepared with known concentrations of analyte or interferents.

8. The sample size for the training set:

This information is not provided in the document. This type of detail is typically associated with machine learning or AI algorithm development, which is not the primary focus of this in vitro diagnostic device submission. The device involves a chemical reaction and photometric measurement, not a "training set" in the machine learning sense.

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

This information is not provided and is not applicable as the device does not involve a "training set" in the context of machine learning. The assay mechanism is based on a defined chemical reaction (diazo colorimetry) rather than a trained algorithm.

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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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alpha-AMYLASE DIRECT: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent institus of in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE EPS: Reagent for the measurement of alpha-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronic pancreatitis. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

alpha-AMYLASE PANCREATIC: Reagent for the measurement of pancreatic c-amylase concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of acute and chronin pancreatitis. This reagentis for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.

BILIRUBIN DIRECT: Reagent for the measurement of direct bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hematological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for use in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

BILIRUBIN TOTAL: Reagent for the measurement of total bilirubin concentration in human serum or plasma. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, herrytological and metabolic disorders, including hepatitis and gall bladder block. This reagent is for nuse in the BioSystems Blockers. Only for in vitro use in the clinical laboratory.

Not Found

This 510(k) summary provides information about the substantial equivalence of several Biosystems S.A. reagents (alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL) to legally marketed predicate devices. It states that the devices are intended for in vitro diagnostic use in the clinical laboratory for measuring specific analyte concentrations in human serum, plasma, or urine, which are useful as aids in the diagnosis and treatment of certain medical conditions. However, the document does not contain any data, studies, or information regarding acceptance criteria or device performance statistics. It is a regulatory clearance letter, not a performance study report.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report that details the validation and performance characteristics of these reagent systems.

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The Direct Bilirubin test system is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma. Bilirubin measurements can be used in the diagnosis and treatment of liver, hematological and metabolic disorders including hepatitis and gall bladder block.

This device is for prescription use only.

The Randox Direct Bilirubin kit consists of ready to use reagent solutions.

CATALOGUE NUMBER: BR8308 COMPONENTS: R1. 4 x 20ml, R2. 4 x 8ml

REAGENT COMPOSITION

R1. Direct Bilirubin RI Tartrate buffer, pH2.9 Detergent Antimicrobials and Preservatives Inhibitors Initial Concentration of Solutions 0.1 mol/L
R2. Direct Bilirubin R2 Phosphate buffer, pH 7.0 Sodium Metavanadate Initial Concentration of Solutions 10 mmol/L 4 mmol/L

Here's a breakdown of the acceptance criteria and the study details for the Randox Direct Bilirubin device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance characteristics but does not explicitly state "acceptance criteria" in a tabulated format derived from a regulatory body or a specific standard with pass/fail thresholds. Instead, it presents the results of various analytical performance studies. However, some sections imply acceptance criteria through their phrasing (e.g., "deviation from linearity is less than 5%" for linearity, "no significant interference" for specificity, and "≤20% CV imprecision" for LoQ).

Here's an interpretation of implied acceptance criteria and reported performance:

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

• Precision/Reproducibility:
  • Sample Size: Not explicitly stated as a number of samples but rather as "control material and unaltered human serum samples" divided into pools (Pool 1, 2, 4) and tested over 20 non-consecutive days with 2 replicates per run. This implies a significant number of measurements for each pool.
  • Data Provenance: "unaltered human serum samples." The country of origin is not specified, but the submission is from the UK. The study is prospective in nature (testing conducted for the device).
• Linearity/Assay Reportable Range:
  • Sample Size: Samples prepared at 11 levels. Each level run in replicates of five.
  • Data Provenance: Not specified, but samples were prepared to cover a range of analyte concentrations. Prospective.
• Detection Limit:
  • Sample Size: 240 determinations (for LoD) with 4 low-level samples.
  • Data Provenance: Not specified. Prospective.
• Analytical Specificity/Interference:
  • Sample Size: Not explicitly stated as a number of samples, but "the analytes detailed below were tested up to the levels indicated at Bilirubin concentrations of 0.14mg/dl and 5.03mg/dl."
  • Data Provenance: Not specified. Prospective.
• Method Comparison with Predicate Device:
  • Sample Size: 103 serum patient samples.
  • Data Provenance: "patient samples." The country of origin is not specified. Likely retrospective, as existing patient samples were used, but the testing itself was prospective.
• Matrix Comparison:
  • Sample Size: A minimum of 40 matched patient sample pairs.
  • Data Provenance: "Patient samples." The country of origin is not specified. Likely retrospective, as existing patient samples were used, but the testing itself was prospective.

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

This device is an in vitro diagnostic (IVD) test for quantitative determination of Direct Bilirubin. The "ground truth" for such devices is typically established through reference methods or established predicate devices, not through expert consensus in the same way an imaging or pathology AI might.

• Precision, Linearity, Detection Limit, Specificity: Ground truth is inherent in the analytical methods themselves (e.g., gravimetric dilutions for linearity, spiked samples, controlled interferent concentrations). No external experts are mentioned.
• Method Comparison and Matrix Comparison: The ground truth for these studies is the measurement obtained by the predicate device (Wako Direct Bilirubin V, K053132) or the matched serum/plasma results themselves. No external experts are described as establishing this "ground truth."

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. Adjudication is typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an automated in vitro diagnostic test, not an AI-assisted human reading device.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are all standalone performance evaluations of the Randox Direct Bilirubin assay system, an automated IVD device. The results reported are directly from the instrument measurements.

7. The Type of Ground Truth Used

• For analytical performance studies (Precision, Linearity, Detection Limit, Specificity): The 'ground truth' is established through controlled laboratory preparations (e.g., known concentrations of analytes, spiked samples, dilutions) and comparisons to established analytical methods as described in CLSI guidelines.
• For method comparison: The 'ground truth' is the predicate FDA-cleared device (Wako Direct Bilirubin V, K053132).
• For matrix comparison: The 'ground truth' is the serum sample measurement when comparing to lithium heparin plasma.

8. The Sample Size for the Training Set

Not applicable. This is a chemical assay, not a machine learning model that requires a training set. The "development" or "optimization" phase of such an assay would involve internal R&D, but it's not a "training set" in the context of AI/ML.

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

Not applicable. There is no training set for an IVD chemical assay as described here. Parameter settings and reagent formulations are determined through standard chemical and biochemical R&D processes, not through machine learning ground truth establishment.

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The ACE Axcel Clinical Chemistry System is an automated, discrete, bench-top, random access analyzer that is intended for in vitro diagnostic use in the quantitative determination of constituents in blood and other fluids.

The ACE Carbon Dioxide (CO2-LC) Reagent is intended for the quantitative determination of carbon dioxide concentration in serum using the ACE Axcel Clinical Chemistry System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Direct Bilirubin Reagent is intended for the quantitative determination of direct bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Total Bilirubin Reagent is intended for the quantitative determination of total bilirubin concentration in serum using the ACE Axcel Clinical Chemistry System. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder block. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Magnesium Reagent is intended for the quantitative determination of magnesium concentration in serum using the ACE Axcel Clinical Chemistry System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The ACE Axcel Clinical Chemistry System consists of two major components, the chemistry instrument and an integrated Panel PC. The instrument accepts the physical patient samples, performs the appropriate optical or potentiometric measurements on those samples and communicates that data to an integral Panel PC. The Panel PC uses keyboard or touch screen input to manually enter a variety of data, control and accept data from the instrument, manage and maintain system information and generate reports relative to patient status and instrument performance. The Panel PC also allows remote download of patient requisitions and upload of patient results via a standard interface.

In the ACE Carbon Dioxide (CO2-LC) Reagent assay, serum carbon dioxide (in the form of bicarbonate) reacts with phosphoenolpyruvate in the presence of phosphoenolpyruvate carboxylase and magnesium to yield oxaloacetic acid and phosphate. In the presence of malate dehydrogenase, the reduced cofactor is oxidized by oxaloacetic acid. The reduced cofactor absorbs strongly at 408 nm whereas its oxidized form does not. The rate of decrease in absorbance, monitored bichromatically at 408 nm/692 nm, is proportional to the carbon dioxide content of the sample.

In the ACE Direct Bilirubin Reagent assay, sodium nitrite added to sulfanilic acid forms diazotized sulfanilic acid. Bilirubin glucuronide in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The increase in absorbance, measured bichromatically at 554 nm/692 nm, one minute after sample addition, is directly proportional to the direct bilirubin concentration.

In the ACE Total Bilirubin Reagent assay, sodium nitrite, when added to sulfanilic acid. forms diazotized sulfanilic acid. Bilirubin in serum reacts with diazotized sulfanilic acid to form azobilirubin, which absorbs strongly at 554 nm. The inclusion of dimethyl sulfoxide (DMSO) in the reagent as an accelerator causes both direct and indirect bilirubin to react rapidly. The increase in absorbance, measured bichromatically at 554 nm/692 nm, is directly proportional to the total bilirubin concentration in the sample.

Magnesium ions in serum react with Xylidyl blue-1 in an alkaline medium to produce a red complex which is measured bichromatically at 525 nm/692 nm. The intensity of color produced is directly proportional to the magnesium concentration in the sample. EGTA prevents calcium interference by preferential chelation of calcium present in the sample.

This document describes the performance of the ACE Carbon Dioxide (CO2-LC) Reagent, ACE Direct Bilirubin Reagent, ACE Total Bilirubin Reagent, and ACE Magnesium Reagent when used with the ACE Axcel Clinical Chemistry System. The study aims to demonstrate substantial equivalence to the predicate device, the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are implicitly established by demonstrating comparability to the predicate device. The performance data presented are the results obtained for the current device and reagents.

The study demonstrates that the ACE Axcel Clinical Chemistry System with the listed reagents achieves precision and accuracy comparable to the predicate device, supporting substantial equivalence.

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

The studies conducted are primarily accuracy (correlation) and precision studies.

• ACE Carbon Dioxide (CO2-LC) Reagent:
  • Accuracy (correlation study): 120 samples.
  • Accuracy (patient correlation studies): Conducted at three separate Physician Office Laboratory (POL) sites; the number of samples per POL site is not specified, but the total across all sites for CO2 values ranged from 3.2 to 47.6 mEq/L.
  • Precision: Four CO2 levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Direct Bilirubin Reagent:
  • Accuracy (correlation study): 116 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Direct Bilirubin values ranged from 0.2 to 12.5 mg/dL.
  • Precision: Four direct bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Total Bilirubin Reagent:
  • Accuracy (correlation study): 117 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Total Bilirubin values ranged from 0.2 to 34.8 mg/dL.
  • Precision: Four total bilirubin levels tested for 22 days; three separate POL sites tested for 5 days.
• ACE Magnesium Reagent:
  • Accuracy (correlation study): 108 samples.
  • Accuracy (patient correlation studies): Conducted at three separate POL sites; the number of samples per POL site is not specified, but the total across all sites for Magnesium values ranged from 0.6 to 5.5 mg/dL.
  • Precision: Four magnesium levels tested for 22 days; three separate POL sites tested for 5 days.

Data Provenance: The document does not explicitly state the country of origin for the data. The "POL sites" (Physician Office Laboratory sites) suggest these are real-world clinical samples, likely from within the United States given the 510(k) submission. The data appears to be prospective in nature, as indicated by the description of testing conducted over 22 days and 5 days at different sites for precision and the collection of samples for correlation studies.

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

This is a clinical chemistry device for quantitative determination. The ground truth is established by comparing the device's measurements against a predicate device (Alfa Wassermann ACE Clinical Chemistry System). Therefore, no human experts are explicitly mentioned as establishing a "ground truth" in the diagnostic interpretation sense. The predicate device itself serves as the reference standard.

4. Adjudication method for the test set

Not applicable. This study involves quantitative measurements by a device and comparison to a predicate device, not qualitative interpretations requiring human adjudication.

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 clinical chemistry analyzer and reagent system, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Yes, the performance data presented are for the standalone algorithm/device (ACE Axcel Clinical Chemistry System with the specified reagents) measuring analytes in samples, compared directly against a predicate device. There is no human-in-the-loop component mentioned in the context of the reported performance data.

7. The type of ground truth used

The type of ground truth used is comparison to a legally marketed predicate device. The ACE Axcel Clinical Chemistry System and its reagents were compared to the Alfa Wassermann ACE Clinical Chemistry System and ACE Reagents (K931786). The predicate device's measurements serve as the reference for established accuracy.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that typically involves a distinct "training set." The device's performance is based on established chemical reactions and detection methods. The studies described are for validation/testing of the device's performance against a predicate, not for training an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the context of this device.

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The ATAC Serum Calibrator 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, direct bilirubin, glucose, iron, magnesium, phosphorus, total bilirubin, total protein, triglycerides, urea and uric acid in human specimens.

Not Found

The provided text is related to the FDA's 510(k) premarket notification for the ATAC Serum Calibrator. It outlines the regulatory approval for this device, which is intended for use with ATAC Clinical Systems to establish reference points for various analytes in human specimens.

However, the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert involvement. It is primarily a regulatory approval letter and an "Indications for Use" statement.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about the study from the given input.

To answer your questions, I would need a document that describes the verification and validation studies performed for the ATAC Serum Calibrator, including:

• Specific performance metrics (e.g., accuracy, precision, linearity).
• The acceptance criteria for each metric.
• The results of the studies demonstrating that these criteria were met.
• Details about the study design, sample characteristics, and how ground truth was established.

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System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers.

Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

For in vitro diagnostic use.

The Olympus Direct Bilirubin Reagent (OSR6X181) is a system reagent.

The provided text is a 510(k) premarket notification acceptance letter from the FDA for a medical device called "The Olympus Direct Bilirubin Reagent (OSR6X181)". This type of document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain the detailed study information, acceptance criteria, or performance data that would allow me to fill out the requested table and answer the specific questions about device performance and validation studies.

The letter focuses on regulatory approval based on substantial equivalence, rather than providing the performance data from the studies that supported that equivalence. To answer your questions, I would need access to the actual 510(k) submission, which typically includes the detailed study reports.

Therefore, I cannot provide the requested information based on the input text.

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Determination of serum and plasma bilirubin is useful in the screening of liver function disorders or in the diagnosis of jaundice.

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the adsorbances before and after the vanadate oxidation.

This document is a 510(k) Summary of Safety and Effectiveness for the Wako Direct Bilirubin V assay. It highlights that the device is based on a chemical oxidation method and can determine direct bilirubin concentration in serum and plasma samples. The primary goal of the submission is to add plasma as an approved sample type to an already existing and approved device (Wako's previous Direct Bilirubin assay, 510(k) #970986).

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific performance acceptance criteria in numerical terms (e.g., sensitivity, specificity, accuracy thresholds). Instead, the crucial acceptance criterion for this 510(k) submission is "substantial equivalency" to the previously marketed device (Wako's Direct Bilirubin assay, 510(k) #970986).

The reported device performance is:

• "shows good correlation with conventional methods"
• "practically no interference by coexistent serum and plasma substances"
• "convenient ready-to-use liquid type reagent"

Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the submission adds the use of plasma as a sample to the previously cleared device. Therefore, any testing related to substantial equivalence for plasma samples would have been conducted, but the specific details are not included in this summary.

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

This submission describes an in vitro diagnostic (IVD) assay for measuring bilirubin, not an imaging device or one requiring expert interpretation of results for ground truth establishment. Therefore, the concept of "experts used to establish ground truth" as it applies to, for example, radiologists interpreting images, is not applicable here. The "ground truth" for chemical assays typically relies on established reference methods, calibrated standards, and a comparison to a predicate device.

4. Adjudication Method for the Test Set

Given that this is an IVD assay and not an imaging or interpretative device, an "adjudication method" in the sense of multiple experts resolving discrepancies is not applicable. Assay results are quantitative measurements, and accuracy is typically assessed against reference methods or the performance of a predicate device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this type of in vitro diagnostic assay. MRMC studies are typically used to evaluate the diagnostic performance of human readers, often with and without AI assistance, in interpreting medical images or other complex data. This device is an automated chemical assay.

6. Standalone Performance Study

The information provided within this summary does not explicitly describe a separate "standalone" study in the way it might be for an AI algorithm. However, the 510(k) submission itself implicitly represents a standalone performance evaluation by comparing its performance to predicate devices (the previous Wako Direct Bilirubin assay) and conventional methods. The core of a 510(k) relies on demonstrating that the new device is "substantially equivalent" in performance to a legally marketed predicate device. This inherently means its performance was evaluated independently to make that claim.

7. Type of Ground Truth Used

The ground truth for chemical assays like this is typically established through:

• Comparison to established, validated reference methods: The summary mentions "good correlation with conventional methods," indicating such comparisons were likely part of the underlying studies.
• Calibrated standards: Assays are typically validated against precisely known concentrations of the analyte (bilirubin in this case).
• Performance of the predicate device: The primary ground truth for this specific submission is the performance of the legally marketed predicate device (Wako's previous Direct Bilirubin assay, 510(k) #970986), against which "substantial equivalency" is claimed.

8. Sample Size for the Training Set

The concept of a "training set" with a specified sample size is primarily relevant to machine learning or AI algorithms. This device is a chemical reagent-based assay. Therefore, a "training set" in the machine learning sense is not applicable. The development of such assays involves extensive R&D, formulation optimization, and analytical validation.

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

As noted above, a "training set" in the context of AI is not applicable for this chemical assay. The validation of the assay's chemical principles and performance would have involved laboratory studies using known bilirubin concentrations, spiked samples, and clinical samples analyzed by reference methods and the predicate device to ensure accuracy, precision, and linearity.

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The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2. The Total Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent 1 (R1) and Reagent 2.

Here's a breakdown of the acceptance criteria and study information for the Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® devices, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance thresholds for each criterion but presents the results of the performance studies. It is implied that these reported performance metrics were considered acceptable for demonstrating substantial equivalence. For instance, the high correlation coefficients (r) suggest strong agreement with the predicate devices, which is a common acceptance criterion for equivalence in such tests.

Study Details

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

   • Direct Bilirubin Test Set:
     • Correlation: 85 samples.
     • Comparison (Plasma vs. Serum): 22 samples.
     • Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
   • Total Bilirubin Test Set:
     • Correlation: 247 samples.
     • Comparison (Plasma vs. Serum): 19 samples.
     • Precision (Intra-assay & Inter-assay): n=20 for each sample level tested.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that these are in vitro diagnostic devices for measuring analytes in human samples, the samples would typically be human serum or plasma.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are quantitative assays for chemical analytes, not image-based or clinical diagnostic tests requiring expert interpretation to establish ground truth in the traditional sense. The "ground truth" for the correlation and comparison studies is established by the results from a "commercially available test" (Roche Direct Bilirubin/Total Bilirubin tests).

3. Adjudication method for the test set: Not applicable. No human interpretation or adjudication process is involved in determining the "ground truth" for these types of quantitative assays.

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 device, not an AI-assisted diagnostic tool that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance data (precision, sensitivity, linearity) represents standalone performance, as it is a fully automated/instrument-based chemical assay. The "correlation" and "comparison" studies are essentially comparisons of the new device's standalone performance against another commercially available standalone device.

6. The type of ground truth used:

   • For Correlation studies, the ground truth was established by the measurements obtained from the predicate devices: Roche Direct Bilirubin (K910593) and Roche Total Bilirubin (K910591).
   • For Precision, Sensitivity, and Linearity, the ground truth is effectively the expected chemical value of the calibrators and samples used in the study, and the assessment is of the device's ability to consistently and accurately measure those values.

7. The sample size for the training set: Not applicable. This is a chemical assay, not an machine learning/AI model that requires training data.

8. 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 Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.

The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.

The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.

The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.

The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials.

Below is a summary of the acceptance criteria and performance study details for the Vitalab Direct Bilirubin Reagent, Vitalab Total Bilirubin Reagent, and Vitalab Bilirubin Calibrator, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

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