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For in vitro diagnostic use to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems.

The Bayer ADVIA® IMS cPSA Controls are bovine serum based with non-serum constituents added. The analytes currently in the control material are: cPSA

This document is a 510(k) summary for the ADVIA® IMS cPSA Control, a quality control material. It describes the device, its intended use, and its substantial equivalence to a predicate device. As a quality control material used to monitor the performance of other assays, the acceptance criteria and study design are different from those for diagnostic devices that detect a disease. This document does not describe a clinical study in the typical sense with patient data, expert readers, or AI performance metrics.

Here's an analysis of the provided text based on the requested information:

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

The document does not explicitly state "acceptance criteria" in the context of performance specifications for the ADVIA® IMS cPSA Control itself. Instead, it describes its intended use as a quality control material "to monitor the precision and the accuracy of the assayed, quantitative complexed PSA assays on the ADVIA® IMS and Bayer Immuno1® systems."

The "reported device performance" of the ADVIA® IMS cPSA Control is implied by its function as a control. The key performance characteristics for such a control material would typically be its assigned values (which establish accuracy) and its stability (which ensures its continued utility for precision monitoring over time). However, these specific values or stability data are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided. The device is a quality control material, not a diagnostic device that processes patient samples or generates diagnostic data. There is no "test set" in the sense of patient data.

3. 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 information is not applicable and not provided. As explained above, there is no "test set" of patient data requiring expert-established ground truth. The "ground truth" for a quality control material would be its manufacturing specifications and assigned analyte values, determined through laboratory methods, not expert consensus on patient cases.

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

This information is not applicable and not provided for the same reasons as above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This device is a quality control material, not an AI-powered diagnostic tool, and therefore no MRMC study or AI-related effectiveness study was performed or is relevant.

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

This information is not applicable and not provided. This device is a quality control material, not an algorithm.

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

For a quality control material, the "ground truth" refers to its assigned analyte values (in this case, cPSA concentration) and its manufacturing specifications. These are established through rigorous laboratory testing during the development and manufacturing process, comparing it against reference materials and methods. The document does not detail how these specific values were established but implies they are part of the product specifications.

8. The sample size for the training set

This information is not applicable and not provided. This device is a quality control material, not a machine learning algorithm, and therefore has no "training set."

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

This information is not applicable and not provided for the same reasons as above.

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For in vitro diagnostic use in the calibration of quantitative PSA assays on the ADVIA® IMS system.
For in vitro diagnostic use in the calibration of quantitative complexed PSA assays on the ADVIA® IMS system.

The Bayer ADVIA® IMS PSA Calibrators and ADVIA® IMS cPSA Calibrators are for values of calibrator material prepared in bovine serum with non-serum constituents added.
The analytes currently in the calibrator material are: PSA in the ADVIA® IMS PSA Calibrator cPSA in ADVIA® IMS cPSA Calibrator

This document is a 510(k) summary for the ADVIA® IMS PSA Calibrator and ADVIA® IMS cPSA Calibrator. It establishes substantial equivalence to a predicate device but does not describe a study that involves performance acceptance criteria against which devices are measured. This type of device (calibrator) would typically undergo studies related to its stability, traceability, and commutability, rather than efficacy studies with clinical endpoints.

Therefore, many of the requested elements for describing an acceptance criteria study are not applicable to the information provided in this document.

Here's a breakdown of the applicable information:

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

   • Not applicable. This document does not present specific performance acceptance criteria for the calibrator itself, nor does it report performance against such criteria. The 510(k) submission focuses on substantial equivalence to a predicate calibrator and its intended use for calibration. Performance of the calibrator would be assessed through its ability to enable accurate and precise measurements by the ADVIA® IMS system when assaying patient samples, which is not detailed here.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not applicable. There is no "test set" in the context of device performance evaluation described in this document.

3. 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):

   • Not applicable. Ground truth establishment by experts is generally not relevant for calibrator devices.

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

   • Not applicable.

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 not an AI-assisted diagnostic device.

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

Summary of Relevant Information from the Provided Text:

• Device Type: In vitro diagnostic calibrator material.
• Intended Use: For in vitro diagnostic use in the calibration of quantitative PSA and complexed PSA assays on the ADVIA® IMS system.
• Substantial Equivalence: The device is deemed substantially equivalent in intended use, storage and handling, stability, source material, and instructions for use to the previously cleared Bayer Lipoprotein Calibrators (K051619). This is the primary "proof" for this type of device according to the 510(k) process – demonstrating it is as safe and effective as a legally marketed predicate device.
• Device Description: Prepared in bovine serum with non-serum constituents added. The analytes are PSA and cPSA.

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The ADVIA IMS® Troponin I Ultra (TnI-Ultra) method is for in vitro diagnostic use to quantitatively measure the cardiac Troponin I in human serum and plasma (lithium heparin). When used in conjunction with other clinical data such as presenting symptoms and diagnostic procedures, measurements of cardiac Troponin I aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with non-ST segment-elevation, acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.

The ADVIA IMS® TnI-Ultra Calibrator is for the in vitro diagnostic use in the calibration of the TnI-Ultra assay on the ADVIA IMS® system

The ADVIA IMS® Troponin I Ultra (TnI-Ultra) method is for in vitro diagnostic use to quantitatively measure the cardiac Troponin I in human serum and plasma (lithium heparin).

The provided text describes the 510(k) summary for the Troponin I Ultra (TnI-Ultra) Assay for Bayer ADVIA IMS®, submitted in 2005. It details the device's intended use and presents performance data by comparing it to a predicate device, the Bayer ACS:180® cTnI Assay.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as clear pass/fail thresholds for each test, but rather presents the performance of the new device (ADVIA IMS® TnI-Ultra Assay) alongside the predicate device (Bayer ACS:180® cTnI Assay) for comparison, implying that similar or improved performance relative to the predicate device is the goal.

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

• Imprecision: The sample size for the imprecision study is not explicitly stated, beyond the "Level" values. The data provenance is not specified (e.g., country of origin, retrospective/prospective).
• Correlation:
  • Sample Size (N): 97 serum specimens.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Interfering Substances: The sample size is not explicitly stated. The data provenance is not specified.
• 99th Percentile Distribution:
  • Sample Size: 337 serum samples from "apparently healthy donors."
  • Data Provenance: Not specified, but implied to be human serum samples.
• Expected Results (AMI patients):
  • Sample Size: 112 AMI patients.
  • Data Provenance: Not specified, but implied to be human serum samples.

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

This type of information (number and qualifications of experts) is not applicable to this analysis. The device is an immunoassay measuring a biochemical marker, where "ground truth" is defined by the laboratory measurement or clinical diagnosis rather than expert interpretation of images or clinical findings in the same way as, for instance, a diagnostic imaging AI. For the 99th percentile, the value is derived statistically from a population of healthy individuals. For AMI patients, the diagnosis (and thus the "ground truth" for the AMI group) would typically be established based on a combination of clinical symptoms, ECG changes, and serial cardiac marker measurements, not a single expert review of a test set in the context of an expert consensus.

4. Adjudication Method for the Test Set

Not applicable for this type of in vitro diagnostic device test. The "truth" in these studies is determined by the analytical measurement or clinical diagnosis criteria, not by human adjudication of independent expert opinions on a specific test result.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes an in vitro diagnostic assay, which is a laboratory test, not an imaging interpretation tool.

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

Yes, the performance presented for the ADVIA IMS® TnI-Ultra Assay (imprecision, correlation, analytical range, minimum detectable concentration, 99th percentile, functional sensitivity, interference) represents its standalone performance as an automated in vitro diagnostic test, without human-in-the-loop performance enhancement for the test's operation itself. Human interpretation is required for the clinical use of the results (e.g., using the TnI-Ultra values in conjunction with other clinical data for AMI diagnosis), but the performance metrics provided are for the assay's analytical capabilities.

7. The Type of Ground Truth Used

• Clinical Diagnosis / Reference Assay Comparison: For correlation with the predicate device, the predicate device's results serve as a comparative "ground truth" or reference.
• Statistical Derivation from Healthy Population: The 99th percentile value is derived statistically from a population of apparently healthy donors.
• Clinical Diagnosis (AMI): For the "Expected Results" table, the "AMI patients" category implies that these individuals had a clinical diagnosis of Acute Myocardial Infarction, which serves as the ground truth for that group.
• Controlled Laboratory Spiking: For interfering substances, the "expected" recovery is the ground truth, and the observed recovery is compared against it.

8. The Sample Size for the Training Set

The document does not explicitly state a "training set" sample size in the context of machine learning or algorithm development. For an immunoassay, the development (akin to "training") involves optimizing reagents, reaction conditions, and calibration, which typically uses a variety of samples but isn't usually quantified as a "training set" in the same way as for AI algorithms. The provided data represents validation studies, not training data for an algorithm.

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

As there is no "training set" described in the context of an AI algorithm, this question is not applicable. The development of an immunoassay involves analytical chemistry and biochemical principles, where "ground truth" during development involves known concentrations, spiked samples, and comparison to established reference methods or clinical samples with known diagnoses.

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The Bayer ADVIA IMS® Glucose assay is an in vitro diagnostic device for use to measure glucose in human serum, plasma, urine and cerebrospinal fluid (CSF) on the ADVIA IMS® System. Such measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and neonatal hypoglycemia.

The ADVIA IMS® Glucose method is based on the combination of hexokinase (HK) and glucose-6-phosphate dehydrogenase (G6PD) for the specific measurement of glucose in serum, plasma, urine and cerebral spinal fluid.

Here's an analysis of the provided 510(k) summary, structured to answer your questions regarding acceptance criteria and the study proving device performance:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the presented performance characteristics. The study demonstrates comparable performance in terms of imprecision and correlation to the predicate device.

• Level ~59 mg/dL: 1.8% (Predicate) | - Level 36 mg/dL: 2.1%
• Level 60 mg/dL: 2.1% |
  | CSF Imprecision (Total CV %) | - Level ~31 mg/dL: 2.7% (Predicate)
• Level ~59 mg/dL: 3.1% (Predicate) | - Level 36 mg/dL: 2.3%
• Level 60 mg/dL: 2.2% |
  | CSF Correlation (Regression Equation Slope) | Expected to be close to 1.0 (indicating good agreement with predicate) | 0.92 |
  | CSF Correlation (Regression Equation Y-intercept) | Expected to be close to 0 (indicating good agreement with predicate) | 2.3 |
  | CSF Correlation (Syx - Residual Standard Deviation) | Not explicitly stated but lower values indicate better fit | 1.9 |
  | CSF Correlation (r - Correlation Coefficient) | Expected to be close to 1.0 (indicating strong correlation) | 0.997 |
  | Analytical Range | Not explicitly stated for predicate in summary, but the predicate likely has a similar range for glucose measurement. | 1 mg/dL - 600 mg/dL |
  | Minimum Detectable Concentration | Not explicitly stated for predicate in summary. | 1 mg/dL |

2. Sample Size and Data Provenance

• Test Set Sample Size: 64 CSF samples were used for the CSF correlation study. The sample sizes for the imprecision studies are not explicitly stated as a single number but are implied by the "Within-run CV" and "Total CV" which typically involve multiple runs and replicates.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable and therefore not provided. The study compares the performance of a new in vitro diagnostic device to a legally marketed predicate device, not against human expert interpretation of images or other subjective assessments. The "ground truth" here is the measurement obtained from the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is a comparison between two quantitative diagnostic devices, not a study involving human interpretation requiring adjudication.

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

No. This study is for an in vitro diagnostic device (glucose assay), not an AI algorithm assisting human readers in diagnostic interpretation. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The entire submission describes the standalone performance of the ADVIA IMS Glucose assay in comparison to the predicate device. There is no human-in-the-loop component for the measurement of glucose in this context.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation is the quantitative measurement obtained from the predicate device, the Bayer ADVIA 1650 Glucose Hexokinase II. The study aims to demonstrate substantial equivalence by showing that the new device's measurements correlate strongly with those of the predicate.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic device based on established biochemical principles (hexokinase and G6PD), not an AI algorithm that requires a "training set" in the machine learning sense. The device is developed and validated through analytical studies, not trained on data.

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

Not applicable, as there is no "training set" for this type of IVD device. The method relies on well-understood chemical reactions.

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The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder.
The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.

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Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Lithium method, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data rather than explicit pre-defined "acceptance criteria" in a go/no-go fashion. However, we can infer performance targets or expectations based on the predicate device's performance and the regression analysis.

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

• Sample Size for Correlation Studies: 49 samples (N=49) for both the comparison with CDC Flame and ThermoTrace systems.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a 510(k) submission, which typically involves internal validation testing by the manufacturer. Assuming typical practices, the samples were likely collected prospectively for the purpose of the study, and the origin is probably related to the manufacturer's testing facilities (e.g., within the US or a region where Bayer operates).

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

• None applicable. This is an in vitro diagnostic device for measuring a chemical analyte (Lithium). "Ground truth" for clinical decisions or image interpretation by experts is not relevant here. The ground truth for the comparison studies is established by reference methods or predicate devices (CDC Flame, ThermoTrace).

4. Adjudication Method for the Test Set:

• None applicable. As detailed in point 3, there are no "experts" in the sense of clinical decision-makers adjudicating results. The comparison methods act as the reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is not relevant for this type of in vitro diagnostic device, which directly measures a chemical concentration rather than assisting human readers in interpreting complex diagnostic information (like medical images).

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

• Yes. The entire submission details the standalone performance of the ADVIA IMS Lithium method. The "device" is the algorithm/system for measuring lithium. There isn't a human-in-the-loop component in the measurement process itself, although a human interprets the numerical results for patient management. The data presented for imprecision, correlation, and interference are all standalone performance metrics.

7. The Type of Ground Truth Used:

• Reference Method/Predicate Device Measurements:
  • For the correlation study with "Comparison System (X) CDC Flame," the ground truth for lithium concentration was established by the Centers for Disease Control (CDC) Flame Photometer, which is a recognized reference method.
  • For the correlation study with "Comparison System (X) ThermoTrace," the ground truth was established by the predicate device, the ThermoTrace Lithium method.
  • For imprecision and interference studies, the ground truth is often established by precise gravimetric or volumetric preparation of known concentrations, confirmed by a reference method.

8. The Sample Size for the Training Set:

• Not explicitly stated/not applicable in the same way as AI/ML. This device is a traditional immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the common sense for model development. The development process would involve method development, reagent formulation, and analytical validation rather than machine learning training.

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

• Not applicable. As described above, this is a traditional in vitro diagnostic assay, not an AI/ML system requiring a training set with established ground truth labels for learning. The "ground truth" during development would be based on known chemical concentrations and performance against established analytical standards.

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This in vitro method is intended to quantitatively measure HDL Cholesterol in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of HDL Cholesterol are used in assessing cardiovascular risk.

The Bayer ADV/A IMS Direct HDL Cholesterol (D-HDL) method is for in vitro diagnostic use to measure HDL Cholesterol in human serum and plasma. Such measurements are used in the risk assessment of cardiovascular diseases.

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Here's a breakdown of the acceptance criteria and study information for the Direct HDL Cholesterol Method for ADVIA® Modular System (IMS), based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical "acceptance criteria" values (e.g., "CV must be

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This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of valproic acid are used to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose.
The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use to measure the antiepileptic drug valproic acid in human serum and plasma. Measurements of valproic acid (2-propylpentanoic acid) are used as an aid in the diagnosis and treatment of valproic acid overdose, and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.

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1. Acceptance Criteria and Reported Device Performance

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The Bayer ADVIA IMS Carbamazepine method is for in vitro diagnostic use to measure the antiepileptic drug carbamazepine in human serum and plasma. Measurements of carbamazepine are used as an aid in the diagnosis and treatment of carbamazepine overdose, and used as an aid in monitoring therapeutic levels of carbamazepine to ensure appropriate therapy.

The Bayer ADVIA IMS Carbamazepine calibrator is for in vitro diagnostic use in the calibration of carbamazepine using the ADVIA® IMS system.

This in vitro method is intended to quantitatively measure the antiepileptic drug carbamazepine in human serum and plasma on the Bayer ADVIA® IMS systems.

1. Acceptance Criteria and Reported Device Performance

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The Bayer Advia IMS C-Reactive Protein (CRP) assay is an in vitro diagnostic device into ded to measure C-Reactive Protein in human serum. Measurements of CRP are used in the evaluation and treatment on injuries to body tissues and in monitoring the progress of traumatic injuries, rheumatic fever and rheumatoid arthritis.

This in vitro method is intended to quantitatively measure C-reactive protein (CRP) in serum on the Bayer ADVIA IMS systems.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the ADVIA IMS High Sensitivity C-Reactive Protein (CRP) Method based on the 510(k) summary:

Acceptance Criteria and Device Performance for ADVIA IMS High Sensitivity C-Reactive Protein (CRP) Method

This device intends to quantitatively measure C-reactive protein (CRP) in serum, primarily for evaluating and treating tissue injuries and monitoring traumatic injuries, rheumatic fever, and rheumatoid arthritis. The study compares the performance of the ADVIA IMS CRP assay against a predicate device, the Dade/Behring N High Sensitivity CRP (K991385).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this diagnostic device are typically established by demonstrating substantial equivalence to a legally marketed predicate device, focusing on analytical performance characteristics such as imprecision, correlation, and interference.

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