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The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.

The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a micronariticle for antibody binding sites of the topiramate antibody reagent. The topiramate-coated micropariticle peagent is rapidly agglutinated in the presence of the anti-topiramate antibody reagent and in the abserved of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a smale containing topiramate is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest topiramate concentration and the lowest agglutination rate at the highest topiramate concentration.

The assay consists of reagents R1: anti-topiramate polyclonal antibody and R2: topiramate-ooated microparticles. A six-level set of Seradyn QMS® Topiramate Cali three-level set of Seradyn QMS® Topiramate Controls is used for quality control of the assay.

Here's an analysis of the Seradyn QMS® Topiramate assay based on the provided 510(k) summary, structured to address your specific points:

Seradyn QMS® Topiramate Assay Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Accuracy: 12 concentrations for recovery study, each analyzed in triplicate (total of 36 measurements).
• Linearity: 9 concentrations, number of replicates not specified.
• Sensitivity (LOQ): Not specified directly, but implies multiple measurements around the LOQ value to determine CV and recovery.
• Precision: 3 controls, N=80 for each (total 240 measurements for precision components).
• Method Comparison: N = 148 patient samples.
• Interference (Endogenous & HAMA): Not explicitly stated, but for each interferent, samples with two known topiramate levels (approx. 5 and 20 µg/mL) were assayed.
• Interference (Co-Administered Drugs): Not explicitly stated, but for each compound, normal human serum with two known topiramate levels (approx. 5 and 20 µg/mL) was assayed.
• Interference (Anticoagulants): Not explicitly stated, but implied comparison of serum and plasma.

Data Provenance: The document does not specify the country of origin of the data. The studies are described as clinical testing, but it's common for these types of in vitro diagnostic studies to use banked or commercially sourced human serum/plasma samples, often without explicit geographical tags in 510(k) summaries. All studies appear to be prospective in the sense that they were designed experiments to evaluate the new device's performance against predefined criteria or a predicate device.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" here is the actual concentration of topiramate in the samples. This is typically established through:

• Reference materials: For linearity and accuracy by recovery, known concentrations are prepared by precise dilution of a high calibrator.
• Reference method/predicate device: For method comparison, the predicate Innofluor® Topiramate assay serves as the reference for comparison of patient sample results.

Therefore, no human experts were used to establish the "ground truth" in the way they would be for image analysis or disease diagnosis. The "ground truth" is defined by laboratory standards, precise dilutions, and the established performance of a reference or predicate method.

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth is quantitative (actual concentration) and not based on human interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging where multiple human readers interpret cases, and AI assistance might impact their performance. For a quantitative IVD assay, the performance is measured directly by analytical metrics (accuracy, precision, linearity, etc.) and comparison to a predicate device or reference method, not by human reader performance.

6. Standalone Performance:

Yes, the studies described (Accuracy, Linearity, Sensitivity, Precision, Specificity, Interferences, Stability) evaluate the algorithm's entire workflow (reagent interaction, measurement, and result calculation) standalone, without human-in-the-loop performance influencing the primary measurements. The assay quantifies topiramate concentration directly.

7. Type of Ground Truth Used:

• Known concentrations: For Accuracy by Recovery, Linearity, Sensitivity studies. These are prepared laboratory standards.
• Predicate device results: For Method Comparison, the results from the Seradyn Innofluor® Topiramate assay (K970510) on patient samples serve as the comparison point.
• Laboratory-spiked samples: For interference studies, known amounts of interferent and topiramate are added to serum samples.

8. Sample Size for the Training Set:

The document does not provide a sample size for a "training set." This assay is a homogeneous particle-enhanced turbidimetric immunoassay (PETIA), which is a chemical reaction-based method, not a machine learning or AI algorithm that typically requires a large "training set" of data in the common sense. The "development" or "optimization" of the assay would involve various experiments, but these are not usually referred to as a "training set" in the context of conventional IVD development. The calibration of the device uses a six-level set of Seradyn QMS® Topiramate Calibrators, but this is for operational calibration, not model training.

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

As noted above, the concept of a "training set" with established ground truth as in AI/ML is not directly applicable to this type of chemical immunoassay. The "ground truth" for calibrators and controls used in assay development and validation would be established through highly accurate reference methods, gravimetric/volumetric preparation, and traceability to established standards for the analyte (topiramate).

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The QMS® Lamotrigine assay is intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.

Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine.

The QMS® Lamotrigine Calibrator set is intended for use in calibration of the QMS Lamotrigine assay.

The QMS® Lamotrigine Control set is intended for use in quality control of the QMS Lamotrigine assay.

The QMS Lamotrigine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.

The assay consists of reagents R1: anti-Lamotrigine sheep polyclonal antibody and R2: Lamotriginecoated microparticles. A six-level set of QMS Lamotrigine Calibrators (A through F) is used to calibrate the assay. A three-level set of QMS Lamotrigine Controls (1 thro the assay.

The provided document describes the K062966 QMS® Lamotrigine assay, a homogeneous particle-enhanced turbidimetric immunoassay for the quantitative determination of lamotrigine in human serum or plasma.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for each performance characteristic. Instead, it describes general methods used for testing and states that performance testing verified the device functions as intended and satisfied design specifications. However, we can infer some criteria and the reported performance from the "SUMMARY OF CLINICAL TESTING" section.

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

The document does not specify the exact sample sizes for the test sets used in each study (Accuracy and Linearity, Sensitivity, Method Comparison, Precision, Specificity, Interferences).

• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. However, given it's a clinical chemistry assay for human serum/plasma, it's highly likely the samples were human biological specimens.

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

This information is not provided in the document. For an in vitro diagnostic (IVD) assay like this, "ground truth" is typically established by reference methods or validated techniques, not necessarily by "experts" in the same way it would be for imaging diagnostics requiring interpretation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and therefore not provided. Adjudication methods are typically relevant for studies involving human interpretation of results (e.g., in imaging or pathology where multiple readers might disagree). For a quantitative chemical assay, the "truth" is determined by the output of a reference instrument or method.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed or described. This type of study is relevant for evaluating the performance of human readers, often aided by AI, in complex diagnostic tasks (e.g., radiology). This device is a quantitative immunoassay, not an AI-assisted diagnostic imaging tool.

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

This device is a standalone assay kit that performs a quantitative measurement on automated clinical chemistry analyzers. The "algorithm" is the biochemical reaction and measurement process itself, not a separate computational algorithm that assists a human. Therefore, the performance described is the standalone performance of the assay system without human interpretation as a primary component of the diagnostic result. The results (lamotrigine concentrations) are then used by clinicians for patient management.

7. Type of Ground Truth Used

The ground truth for this type of quantitative assay would typically be established by:

• Reference Methods: Highly accurate and precise analytical methods (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS)) for determining the true concentration of lamotrigine in samples.
• Spiked Samples: Known concentrations of lamotrigine added to a matrix (e.g., human serum or plasma that is negative for lamotrigine) to assess accuracy and linearity.
• Patient Samples: Used for method comparison against a legally marketed predicate device or a well-established reference method.

The document implicitly refers to these by mentioning "Accuracy and linearity were determined..." and "Correlation studies were conducted using patient samples..." indicating that the "ground truth" for those studies would have been the results from a reference method or the assigned values from spiked samples.

8. Sample Size for the Training Set

The document does not mention a training set because this is a traditional immunoassay, not a machine learning or AI-based device that requires "training." The "training" of such a system involves developing the reagents and optimizing the assay conditions.

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

As there is no "training set" in the context of machine learning, this question is not applicable. The development of the assay's reagents and protocols is based on extensive biochemical research and optimization studies rather than "ground truth" established for a training dataset.

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ARCHITECT® Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders.

The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cortisol in human serum, plasma or urine.

The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma or urine using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

Here's a breakdown of the acceptance criteria and study details for the ARCHITECT Cortisol assay:

1. Table of Acceptance Criteria and Reported Device Performance:

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The QMS® Tobramycin assay is intended for the quantitative determination of tobramycin in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to help ensure appropriate therapy.

The QMS® Tobramycin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti- tobramycin monoclonal antibody and R2: tobramycin -coated microparticles. A six-level set of QMS® Tobramycin Calibrators (A through F) is used to calibrate the assay.

Here's a breakdown of the acceptance criteria and study information for the Seradyn QMS® Tobramycin assay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

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The Multigent® Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of Gentamicin overdose and in monitoring levels of Gentamicin to ensure appropriate therapy.

The Multigente Gentamicin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.

This document describes the acceptance criteria and the studies performed to demonstrate the performance of the Multigent® Gentamicin assay.

1. Table of Acceptance Criteria and Reported Device Performance:

Note regarding Rheumatoid Factor interference: The reported % Recovery (132.34%) for Rheumatoid Factor at 582 IU exceeds the stated acceptance criteria of 100 ± 10%. This indicates potential interference from high levels of Rheumatoid Factor, which should be noted in the device labeling.

2. Sample Size and Data Provenance:

• Accuracy: 5 samples (0.25, 1.00, 2.25, 4.50, 8.00 µg/mL) each run in triplicate (total of 15 measurements in the table shown). Data provenance not specified (retrospective/prospective, country of origin).
• Linearity: 4 serially diluted samples (6.88, 5.16, 3.44, 1.72 MG/ML) each run in triplicate (total of 12 measurements in the table shown). Data provenance not specified.
• Precision: 3 control levels (low, mid, high) tested, with N=80 for each (number of replicates over time). Data provenance not specified.
• Sensitivity: Calibrator A (0 µg/mL) run for a total of 20 replicates. Data provenance not specified.
• Interferences (Endogenous Substances):
  • Bilirubin: 3 replicates for "N=3" (interpreted as the number of independent samples or measurement replicates, as the "N" column is inconsistent).
  • Hemoglobin: 2 replicates for "N=2".
  • Triglyceride, Total Protein: "N" is listed as a non-numeric character (presumably an error in transcription, but the text mentions "run in triplicate" for triglyceride and total protein).
  • Rheumatoid Factor: "N" is listed as a non-numeric character (text mentions "run in triplicate").
  • Data provenance not specified.
• Interferences (HAMA): Duplicate HAMA samples (Type-1 and Type-2) and duplicate control samples. Data provenance not specified.
• Interferences (Common Co-Administered Drugs): Test samples and control samples assayed in duplicate for each drug. Data provenance not specified.
• Anticoagulants: Blood drawn from at least ten healthy donors for each of the 9 tube types. Samples were spiked with Gentamicin and run in duplicate. Data provenance not specified.
• Method Comparison: 55 serum and plasma samples, ranging from 0.78 to 9.02 µg/mL Gentamicin. Data provenance not specified.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" for chemical concentration assays is typically established by reference methods, primary standards, or gravimetric/volumetric preparation of known concentrations. There is no mention of human "experts" establishing ground truth in the traditional sense of clinical opinion (e.g., radiologists, pathologists). The ground truth for performance studies like accuracy and linearity is based on the theoretical concentrations of prepared samples or reference materials. For method comparison, the predicate device (Abbott TDx®/TDxFLx® Gentamicin assay) serves as the reference method.

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

Not applicable. Adjudication methods are typically used in studies involving subjective assessment (e.g., image interpretation) where multiple readers provide independent evaluations that might conflict. For quantitative chemical assays, the result is a numerical value, and "adjudication" is not a standard practice. Statistical methods are used to compare results to expected values or reference methods.

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 in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

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

The performance studies described (Precision, Accuracy, Linearity, Sensitivity, etc.) represent the standalone performance of the Multigent® Gentamicin assay system. The device itself generates a quantitative result without direct human interpretation of a visual output. The human-in-the-loop would be the laboratory personnel operating the Architect C8000 System and interpreting the numerical result in a clinical context.

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

The ground truth for this device's performance relies on:

• Theoretical Concentrations: For accuracy, linearity, and sensitivity studies, known concentrations of Gentamicin in control matrices serve as the ground truth. These are typically prepared using gravimetric or volumetric methods with highly pure reference standards.
• Reference Method: For the method comparison study, the Abbott TDx®/TDxFLx® Gentamicin assay served as the reference (or comparative) method, with its results considered the "ground truth" for evaluating the new device's correlation.

8. The sample size for the training set:

Not applicable. This device is a chemical immunoassay, not a machine learning or artificial intelligence system that requires a "training set" in the computational sense. The assay works based on established biochemical principles and reagents rather than being "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 in vitro diagnostic device.

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The QMS® Quinidine assay is intended for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy.

The QMS® Quinidine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.

In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS® Quinidine Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.

The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the The absorbance of unknown samples can be interpolated from the absorbance values of the drug, calibration curve and the concentration of the drug present in the sample can be calculated.

The assay consists of reagents R1: anti-quinidine monoconal and R2: quinidine-oated microparticles. A six-level set of QMS® Quinidine Calibrators (A throu

Here's a breakdown of the acceptance criteria and study information for the QMS® Quinidine assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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The QMS Zonisamide assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers.

Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.

The QMS® Zonisamide Calibrator set is intended for use in calibration of the QMS Zonisamide assay.

The QMS® Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay.

The QMS Zonisamide assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.

The assay consists of reagents R1: anti-Zonisamide rabbit polyclonal antibody and R2: Zonisamidecoated microparticles. A six-level set of QMS® Zonisamide Calibrators (A through F) is used to calibrate the assay. A three-level set of QMS® Zonisamide Controls (1 through 3) is used for quality control of the assay.

The provided text describes the QMS® Zonisamide assay, a homogeneous particle-enhanced turbidimetric immunoassay for the quantitative determination of zonisamide in human serum or plasma. The information focuses on demonstrating its substantial equivalence to a legally marketed predicate device (Innofluor® Phenytoin) through performance testing.

Here's an analysis of the acceptance criteria and the studies performed, formatted as requested:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state the sample sizes used for the test sets in the accuracy, linearity, method comparison, precision, specificity, or interference studies.

Regarding data provenance:

• The studies were conducted using well-established NCCLS guidelines, implying standardized laboratory testing.
• The method comparison used "patient samples," suggesting a clinical context, but no specifics about country of origin or whether it was retrospective or prospective are provided.

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

This information is not provided in the document. The studies described are primarily analytical performance studies of a quantitative assay, where the "ground truth" for assay accuracy and calibration would typically be established by reference methods or gravimetric preparation of standards, not by human expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore, not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., image analysis, clinical diagnosis) where there might be inter-reader variability. For an automated quantitative assay, the "ground truth" is typically determined by objective reference methods or precise measurements, not by expert consensus adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve significant human interpretation (e.g., radiologists reading images) and the AI's impact on human performance. The QMS® Zonisamide assay is a quantitative determination assay performed on automated clinical chemistry analyzers, not an interpretive diagnostic tool requiring human readers in that sense.

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

Yes, the studies described are inherently standalone performance tests of the assay. The QMS® Zonisamide assay is a laboratory test system designed to provide quantitative results directly from automated analyzers. The reported performance metrics (accuracy, linearity, sensitivity, precision, specificity, interferences) evaluate the device's capability to accurately and reliably measure zonisamide concentrations without direct human interpretation influencing the measurement outcome.

7. The Type of Ground Truth Used

The ground truth for this type of quantitative assay would typically be established through:

• Reference Methods / Gravimetric Standards: For accuracy and linearity, highly precise and accurate reference methods or gravimetrically prepared standards with known zonisamide concentrations would be used.
• Known Concentrations: For sensitivity, specificity, and interference studies, samples with precisely known concentrations of zonisamide, metabolites, or interfering substances would be utilized.
• Patient Samples: For method comparison studies, the "ground truth" would be the results obtained from an established comparative method on actual patient samples.

The document does not explicitly detail the exact methods used for establishing ground truth for each study but implies standard laboratory practices using "patient samples" for method comparison and reference to NCCLS guidelines for other analytical performance.

8. The Sample Size for the Training Set

This information is not applicable and therefore, not provided. The QMS® Zonisamide assay is a biochemical immunoassay, not a machine learning or AI algorithm that requires a separate "training set" in the context of supervised learning. The assay's performance is driven by its reagent formulation, reaction kinetics, and instrument calibration, not by an algorithm trained on a dataset.

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

This information is not applicable as there is no "training set" in the context of an immunoassay. The chemical and biological principles of the assay itself, along with the manufacturing and quality control of the reagents and calibrators, establish its analytical performance capabilities.

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The QMS® Amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

The QMS® Amikacin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.

In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS Amikacin Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance.

The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the drug. The absorbance of unknown samples can be interpolated from the absorbance values of the calibration curve and the concentration of the drug present in the sample can be calculated.

The assay consists of reagents R1: anti-amikacin monoclonal antibody and R2: amikacin-coated microparticles. A six-level set of QMS® Amikacin Calibrators (A through F) is used to calibroothe assay.

Here's a breakdown of the acceptance criteria and study information for the QMS® Amikacin assay, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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The QMS® Vancomycin assay is intended for the quantitative determination of vancomycin in human serum or plasma on the Hitachi 717 analyzer.

The results obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The QMS® Vancomycin assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the vancomycin antibody reagent. The vancomycin-coated microparticle reagent is rapidly aqglutinated in the presence of the anti-vancomycin antibody reagent and in the absence of any competing drug in the sample. The rate of absorbance change is measured photometrically, and is directly proportional to the rate of agglutination of the particles. When a sample containing vancomycin is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentrationdependent classic agglutination inhibition curve can be obtained, with maximum rate of agglutination at the lowest vancomycin concentration and the lowest agglutination rate at the highest vancomycin concentration.

The assay consists of reagents R1: vancomycin monoclonal and R2: vancomycin-coated microparticles. A six-level set of QMS® Vancomycin Calibrators (A through F) i

Here's a summary of the acceptance criteria and study findings for the QMS® Vancomycin assay, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for QMS® Vancomycin Assay

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for all tests. Instead, it presents study results and implies that the observed performance characteristics were deemed acceptable for substantial equivalence to the predicate device. For the purpose of this table, "Acceptance Criteria (Implied)" are derived from the overall goal of demonstrating equivalency or typical performance expectations for such assays, and "Reported Device Performance" are the results presented in the summary.

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