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The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.

The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Albumin BCP2 assay is an automated clinical chemistry assay. The Albumin BCP2 procedure is based on the binding of bromocresol purple specifically with human albumin 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 Purple)

This document is a 510(k) premarket notification for a new in vitro diagnostic device, the Albumin BCP2 assay, which measures albumin in human serum or plasma. It seeks to prove substantial equivalence to a predicate device, Albumin BCP.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table with pass/fail thresholds for each performance characteristic. Instead, it describes various studies conducted and reports the results, implying that meeting standard analytical performance metrics demonstrates acceptable performance and substantial equivalence.

However, we can infer the acceptance criteria from the reported performance and the context of typical FDA 510(k) submissions for in vitro diagnostic assays. The studies are designed to demonstrate the new device performs comparably to established standards and the predicate device.

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

The document describes test methods rather than specific "test sets" in the context of an AI/ML algorithm that might have a dedicated validation dataset. Instead, for an in-vitro diagnostic device, studies are conducted across various analytical performance characteristics.

• Precision Study: "2 controls and 3 human serum panels were tested in duplicate, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations." This means 80 data points for each control/panel (2 tests/day * 20 days * 2 replicates).
• Accuracy Study: "2 lots of the Albumin BCP2 reagent, 2 lots of the Consolidated Chemistry Calibrator, and 1 instrument." (No specific sample count for patient samples, but implied to be sufficient for bias estimation against a reference material).
• Lower Limits of Measurement: "n ≥ 60 replicates of zero-analyte samples" for LoB, and "n ≥ 60 replicates of low-analyte level samples" for LoD and LoQ.
• Linearity: No specific sample size mentioned, but typically involves preparing multiple dilutions.
• Interference Study: "Each substance was tested at 2 levels of the analyte (approximately 3.5 g/dL and 5.0 g/dL)."
• Method Comparison: 127 serum samples.
• Tube Type: "Samples were collected from a minimum of 40 donors".
• Dilution Verification: 5 human serum samples prepared by spiking.

Data Provenance: The document doesn't explicitly state the country of origin for the human samples used in the studies. Given that Abbott Ireland Diagnostics Division submitted the application, the studies were likely conducted in a setting compliant with international standards, possibly in Ireland or the US given the FDA submission. The studies described are nonclinical laboratory studies, not human clinical trials. They are retrospective or prospective in the sense of laboratory-controlled experiments designed to evaluate performance characteristics.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This section is not applicable as this is an in-vitro diagnostic (IVD) device, specifically a clinical chemistry assay, not an AI/ML diagnostic software. The "ground truth" for an IVD device is established through:

• Reference Methods: Using highly accurate and precise laboratory methods (e.g., mass spectrometry, enzymatic methods, or other established validated assays) or certified reference materials (like ERM-DA470k/IFCC for accuracy testing).
• Standardization: Traceability to international standards (like IFCC).
• Analytical Performance: Rigorous testing against defined analytical parameters (precision, linearity, limits of detection/quantitation).

There is no "ground truth" derived from human expert consensus for this type of device.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as #3. Adjudication methods (like 2+1, 3+1) are common in AI/ML studies where human readers are establishing ground truth for image interpretation or similar tasks. For an IVD assay, performance is judged against analytical accuracy and precision, not human consensus on results.

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

This is not applicable. MRMC studies are specific to AI/ML software that assists human readers (e.g., radiologists, pathologists) in interpreting medical images or data. This device is a quantitative laboratory assay. There is no human "reader" assisted by this device in the same way. The device directly measures a biochemical analyte.

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

This isn't an "algorithm" in the AI/ML sense but rather a chemical assay method run on an automated analyzer. The entire performance data presented (precision, accuracy, linearity, interference, method comparison) represents the "standalone" analytical performance of the assay without human intervention influencing the measurement itself. Human involvement is in the operation of the instrument, quality control, and interpretation of the results, but not in the measurement process being evaluated here.

7. Type of Ground Truth Used:

The ground truth for this chemical assay is primarily established by:

• Standard Reference Materials (SRMs): For accuracy, the device's results are compared against ERM-DA470k/IFCC, which are certified reference materials with highly accurate assigned values.
• Reference Measurement Procedures: Implied by the use of standard methods and CLSI (Clinical and Laboratory Standards Institute) guidance, which dictates how analytical performance (e.g., LoB, LoD, LoQ, linearity, precision) should be determined using robust statistical methods and replicates.
• Predicate Device Comparison: For method comparison, the "ground truth" (or comparative truth) is the performance of the legally marketed predicate device (Albumin BCP) on patient samples.

8. Sample Size for the Training Set:

This concept of a "training set" is specific to AI/ML models. For an IVD assay, calibration and internal method development (which could be analogous to "training") would involve various reagent lots, calibrators, and QC materials provided by the manufacturer. The document does not specify a "training set size" in the AI/ML context because the development of a chemical assay follows different principles.

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

Again, this is not applicable in the AI/ML sense. For chemical assays, the establishment of the assay (analogous to "training") involves:

• Reagent Formulation and Optimization: Developing the chemical reagents (Bromocresol Purple, buffers, etc.) to ensure proper reaction kinetics, stability, and specificity.
• Calibrator Assignment: Assigning accurate values to calibrator materials used by the assay, often traceable to international standards (like ERM-DA470/IFCC).
• Method Development on Platform: Optimizing the assay parameters (volumes, incubation times, temperatures, wavelength) on the specific ARCHITECT c System to achieve optimal performance.
• Internal Validation: Initial testing during development to ensure the assay performs as expected before formal verification and validation studies are conducted for regulatory submission. This internal validation would use similar principles of analytical testing as described in Section 8 (e.g., accuracy, precision, linearity using reference materials and pooled human samples).

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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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The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The assay is intended for professional use only.

For In Vitro Diagnostic use only.

Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.

Here's the breakdown of the acceptance criteria and study information for the Albumin BCP device, based on the provided text:

Acceptance Criteria and Device Performance

Note regarding "Test Set" and "Training Set" terminology: For in vitro diagnostic assays measuring specific analytes, the concepts of "test set" and "training set" (as typically used in machine learning or image analysis) are not directly applicable in the same way. Instead, performance studies use different sample types (e.g., control materials, patient samples, spiked samples) to validate the analytical performance characteristics. The following answers reflect this distinction.

Study Details:

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

   • Limit of Blank (LoB): Not explicitly stated, but performed with three different reagent lots (F0390, F0391, F0480) and one calibrator lot (E0179). LoB is typically determined using replicate measurements of blank samples.
   • Limit of Detection (LoD): Not explicitly stated, but inferred to be similar to LoB determination as it also uses reagent and calibrator lots.
   • Limit of Quantitation (LoQ): Not explicitly stated, inferred to be similar to LoB/LoD determination.
   • Precision Study: 80 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (26.26-26.62 g/L, 40.53-40.67 g/L, 49.96-50.47 g/L) using human serum. An additional lot (90228) used 88 replicates per level (19.10 g/L, 40.18 g/L, 51.33 g/L).
   • Intra Assay Precision Study: 20 replicates per level for three different reagent lots (F0390, F0391, F0480) across three levels (21.4-21.5 g/L, 35.6-35.8 g/L, 50.2-50.3 g/L) using human serum.
   • Linearity (Measuring Range): Three different reagent lots (F0390, F0391, F0480) were tested across specified ranges (e.g., 4.17 to 78.30 g/L). Number of distinct samples within these ranges not explicitly stated.
   • Endogenous Interferences Study: "2 aliquots of serum pool were prepared (Base and Test pool)" for two albumin concentrations (~35 g/L and ~50 g/L), with the test pool divided into 4 sub-aliquots and diluted. Specific number of interference samples not stated, but covered a range of dilution levels (100% down to 0%).
   • Reagent Stability: Four different lots (F0390, F0391, F0480, 90228) were evaluated across three different concentration levels.
   • Method Comparison: 128 serum samples, including 8 altered samples, covering the measuring interval 6.0 - 70 g/L.
   • Matrix Comparison: 77 paired plasma/serum samples, including 7 altered samples, covering the assay's range, for both Lithium-Heparin plasma and Potassium EDTA plasma.

   Data Provenance: The studies used human serum and plasma samples. The document does not explicitly state the country of origin of the data or whether the samples were collected retrospectively or prospectively. Given the context of a medical device submission, these would typically be from clinical laboratory settings.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   This is an in vitro diagnostic (IVD) assay for measuring a biochemical analyte (albumin). The "ground truth" for such assays is established by the reference methods or highly characterized materials used to calibrate and validate the assay. It does not involve human experts interpreting images or diagnosing conditions, but rather relies on established analytical standards and predicate devices.

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

   Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., image reading) where disagreement among experts might arise. For quantitative IVD assays, performance is assessed against defined analytical criteria and reference values.

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 would involve human readers.

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

   Yes, the performance studies described are for the standalone functioning of the Albumin BCP assay on the AU680 Automatic Analyzer. This is inherent to the nature of an in vitro diagnostic test, where the device performs the measurement independently.

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

   The "ground truth" for this IVD device is established through:

   • Reference materials and calibrators: Used to ensure accuracy and traceability of measurements (e.g., ERM-DA 470k/IFCC for standardization).
   • Predicate device measurements: The method comparison study used a legally marketed predicate device (Siemens ADVIA 2400, ADVIA® Chemistry Albumin BCP assay) as a comparative standard.
   • Analytical standards: Performance is measured against accepted analytical performance guidelines (e.g., CLSI documents EP17-A2, EP05-A3, EP15-A3, EP6-A, EP07-A2, EP09-A3) which define acceptable limits for various performance characteristics.
   • Known concentrations: For studies like LoB, LoD, LoQ, Precision, and Intra-Assay Precision, samples with known or characterized concentrations (e.g., control materials, spiked samples, serum pools) are used to assess the device's accuracy and reproducibility.

7. The sample size for the training set:

   Not applicable in the machine learning sense. The device is a chemical assay, not an algorithm trained on a dataset. Its analytical characteristics are inherently designed and validated through laboratory studies.

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

   Not applicable. As explained above, this device does not utilize a "training set" in the context of machine learning. The analytical methods and performance targets are established through scientific principles of chemistry and validated using established laboratory practices and reference standards.

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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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The Albumin Cobalt Binding Test (ACB® Test) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.

Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndromes (ACS) in low risk patients.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Albumin Cobalt Binding Test (ACB® Test)". It states the device's intended use and includes a required limitation in the labeling. However, it does not contain specific details about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a more comprehensive FDA submission summary.

Therefore, much of the requested information cannot be extracted from this document.

Here's what can be gleaned, along with the information that is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document primarily grants substantial equivalence based on a predicate device and outlines labeling requirements and limitations. It does not provide a table of acceptance criteria or specific performance metrics from a study (e.g., sensitivity, specificity, NPV, PPV) for the ACB® Test.

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

Missing. No information on the sample size of a test set or the provenance (country of origin, retrospective/prospective) of data used to establish device performance is provided.

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

Missing. There is no mention of experts, how ground truth for a test set was established, or their qualifications.

4. Adjudication Method for the Test Set

Missing. No adjudication method is described.

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

Missing. The document does not indicate that an MRMC study was performed or provide any effect size of human readers improving with or without AI assistance (which is not relevant for this type of in-vitro diagnostic device).

6. Standalone (Algorithm Only) Performance Study

Missing. While this is an "in vitro diagnostic product," the document doesn't detail any specific standalone performance study results.

7. Type of Ground Truth Used

Missing. The document states the device "detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum" and is intended "as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin." It also mentions "normal troponin" and "non-diagnostic ECG" in its indications for use. However, it does not explain how the "ground truth" for ACS or risk stratification was established in any study to validate the device's performance.

8. Sample Size for the Training Set

Missing. No information on a training set sample size is provided.

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

Missing. No information on how ground truth was established for a training set is provided.

In summary: This FDA letter focuses on regulatory approval and labeling limitations rather than a detailed scientific study summary. To obtain the requested information, one would typically need to review the full 510(k) submission, including the clinical and analytical performance studies, which are not part of this document.

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An albumin test system is an in vitro device intended to measure albumin concentration quantitatively in serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for a medical device. The document is a 510(k) clearance letter from the FDA for an "Albumin Reagent" device, indicating that it has been found substantially equivalent to a legally marketed predicate device. It defines the intended use of the device but does not include any performance data or a description of a study.

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THE Albumin BCG reagent is intended for Invitro diagnostic in the quantitative determination of albumin in serum use or plasme.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to A.P. Total Care, Inc. regarding their "Albumin BCG" reagent. This document is a regulatory approval letter and does not contain the detailed information necessary to answer the questions about acceptance criteria and study design for a device.

The letter confirms the device is substantially equivalent to legally marketed predicate devices and is intended for in vitro diagnostic use in the quantitative determination of albumin in serum or plasma. It mentions general regulatory compliance but does not include any specific performance data, study designs, sample sizes, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. To answer these questions, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, would be required.

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