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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:

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

• Linearity: The study used a "regression analysis plot" and involved constructing "r regression and regression standard error (Reg SE)" for "each pool." The number of unique samples or data points for each dilution is not explicitly stated in the table, but it shows results for dilution range from 0% to 100% for two serum pools (65 ug/dL and 8 ug/dL). The guidance used was NCCLS guideline EP6-A. Provenance is not specified (e.g., country, retrospective/prospective).
• Accuracy: Cortisol was spiked into human serum from 3 donors and human urine from 3 donors. The samples were analyzed in triplicate. Provenance is not specified.
• Sensitivity:
  • LoB and LoD: 60 blank samples and 120 low-level samples were used to determine LoB and LoD.
  • Functional Sensitivity: Not explicitly stated, but based on CLSI guideline NCCLS EP17-A.
    Provenace of samples not specified.
• Method Comparison: Patients samples were used (serum and urine). The number of samples is not provided. The study was conducted according to CLSI Guideline NCCLS EP9. Provenance not specified.
• Precision:
  • 80 replicates (n=80) for each of the three MCC (Multi-constituent Control) levels and three serum panel levels on both the i2000 and i2000SR instruments.
  • 80 replicates (n=80) for each of the four urine panel levels on both the i2000 and i2000SR instruments.
    The study was performed using NCCLS guideline EP5-A2. Provenance not specified.
• Interferences (Endogenous Substances):
  • Serum: 3 replicates (N=3) for each interferent concentration and Cortisol target concentration.
  • Urine: Data represents a comparison of "Unaltered Urine Control" vs. "Mock spike Control" and then individual interferents. Number of replicates not explicitly stated, but implies multiple measurements.
    The study was conducted using CLSI Guideline NCCLS EP7-A2. Provenance not specified.
• Interferences (HAMA & RF):
  • HAMA: 10 samples (HAMA-1, HAMA-2 and 8 other samples) were tested.
  • Rheumatoid Factor (RF): 10 positive RF patient samples were assayed.
    Provenance not specified.
• Specificity: Cortisol was spiked into cortisol-free human serum. Cross-reactant stock concentrates were prepared and spiked into aliquots of the 12 ug/dL cortisol serum. The total number of unique samples/aliquots is not precisely stated but involves a comprehensive list of 37 cross-reactants. Provenance not specified.
• On-Board Stability: Details on the sample size used for stability studies (number of samples, replicates, etc.) are not provided in the summary. Provenance not specified.

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

The device is an in vitro diagnostic (IVD) assay for quantitative determination of cortisol. The "ground truth" for such devices is typically established through a reference method or known concentrations of analytes, not through human expert interpretation of images or clinical cases. Therefore, the concept of "experts" as in "radiologists with 10 years of experience" is not applicable here.

• For studies like linearity, accuracy (recovery), sensitivity, and precision, the ground truth is based on:
  • Known concentrations: For spiked samples and controls.
  • Reference method values: For method comparison (in this case, the predicate device Abbott AxSYM Cortisol assay).
• No information is provided about clinical expert adjudication or establishment of ground truth in the context of clinical expert review.

4. Adjudication Method for the Test Set:

Not applicable. As this is an IVD assay measuring an analyte concentration, the results are quantitative and compared against expected values, known concentrations, or results from a predicate device. There is no mention of a human expert adjudication process (e.g., 2+1, 3+1) because that process is typically associated with subjective interpretation tasks (like image review) where there can be disagreement among experts.

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

No. An MRMC study is not relevant for this type of IVD device. MRMC studies are typically used to evaluate the impact of AI on human reader performance, for instance, in diagnostic imaging where human readers interpret cases. This submission is for a standalone laboratory assay that quantifies a biomarker.

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

Yes, the studies presented (linearity, accuracy, sensitivity, precision, interferences, specificity, stability) all represent the standalone performance of the ARCHITECT Cortisol assay without human-in-the-loop assistance in the interpretation of the assay result itself. The assay directly outputs a quantitative value. The human involvement is in performing the test and reviewing the quantitative result, but not in interpreting subjective data for diagnostical decision-making.

7. The Type of Ground Truth Used:

The ground truth used for these studies includes:

• Known (prepared) concentrations: For linearity panels, spiked accuracy samples (serum and urine), and sensitivity studies (blank and low-level samples).
• Reference method/predicate device comparison: For method comparison, the Abbott AxSYM Cortisol assay served as the comparative "truth" or reference method to demonstrate substantial equivalence.
• Defined control material values: For precision studies (MCC samples).

8. The Sample Size for the Training Set:

This information is not applicable to this type of traditional in vitro diagnostic assay. These assays are developed through chemical and biological formulation and optimization, not through machine learning models that require distinct training sets. The development process involves extensive experimentation and validation, but not in the "training set" sense of AI/ML.

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

This information is not applicable for the same reason as above. There is no "training set" in the context of machine learning for this device. The development and optimization of the assay's reagents and protocols are based on established analytical chemistry principles and performance characteristics, validated against known standards and reference materials.

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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

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

• Accuracy: Samples analyzed in duplicate. The number of samples for the accuracy study was 3 "theoretical concentrations" of quinidine (2.0, 4.0, 8.0 µg/mL), each tested in duplicate (total 6 measurements).
• Linearity: Not explicitly stated as a number of individual samples, but the study was "based on the NCCLS guideline EP6: Evaluation of the Linearity of Quantitative Measurement." It involved testing 5 theoretical concentrations (0.25, 0.75, 1.5, 3.0, 6.0 µg/mL), each in duplicate.
• Method Comparison: N = 50 (number of patient samples)
• Precision: 80 measurements per control level (for 3 control levels, so 240 total measurements).
• Specificity: N=3 for each cross-reactant.
• Interferences (Endogenous Substances): N=2 for Bilirubin and Hemoglobin, N=3 for Triglyceride and Total Protein.
• Interferences (HAMA): Samples analyzed in duplicate for Control, HAMA Type-1, HAMA Type-2.
• Data Provenance: The document does not specify the country of origin for the human serum/plasma samples. It states that accuracy was determined by spiking USP traceable quinidine into "human serum negative for the drug." Method comparison used "patient samples." The studies appear to be retrospective in nature, as they are laboratory-based validation studies.

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 for this device and study. The QMS® Quinidine assay is an in vitro diagnostic (IVD) device for quantitative determination of a drug in serum/plasma. Its performance is evaluated against established analytical methods and reference standards, not by human expert interpretation of images or clinical data for ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the studies involve quantitative measurements and comparisons to reference values or other assays, not human interpretation requiring 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 done. This type of study is typically used for medical imaging devices where human readers interpret cases with and without AI assistance. This document describes the analytical performance of a quantitative immunoassay.

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 QMS® Quinidine assay. The device itself is an automated clinical chemistry analyzer for quantitative determination, meaning it operates without direct human interpretive input beyond sample loading and results reporting. The performance metrics (accuracy, linearity, precision, etc.) are inherent to the assay's ability to measure quinidine concentrations.

7. The Type of Ground Truth Used

The ground truth for the various studies includes:

• Spiked Concentrations: For accuracy and linearity, USP traceable quinidine was spiked into human serum to create samples with known theoretical concentrations.
• Reference Method Results: For method comparison, the Abbott TDx/TDxFLx Quinidine assay served as the reference method, and its results were compared to the QMS® Quinidine assay.
• Known Concentrations/Materials: For sensitivity, specificity, and interference studies, samples with known concentrations of drug, cross-reactants, or interfering substances were used.

8. The Sample Size for the Training Set

The document describes the validation studies for the QMS® Quinidine assay. For an IVD device like this, the "training set" would typically refer to the data used during the development and optimization of the assay's reagents and methodology. This information is not provided in this 510(k) summary, as it generally focuses on the final validation results, not the developmental process.

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

As the "training set" information is not provided, the method for establishing its ground truth is also not available in this document. During development, ground truth would likely be established using highly accurate reference methods, certified reference materials, and meticulously prepared known-concentration samples, similar to the validation methods but on a smaller scale and iteratively.

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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

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

• Accuracy: Samples were spiked human serum. No specific number for "samples analyzed" is given, but it mentions "in duplicate." The specific source/country of the human serum is not mentioned. This appears to be a laboratory-controlled, prospective study.
• Linearity: Not explicitly stated, but based on "a study based on the NCCLS guideline EP6." A set of 5 theoretical concentrations was tested, each in duplicate. USP Amikacin was used, indicating an in vitro, laboratory-controlled prospective study.
• Sensitivity: Not explicitly stated, but related to the lowest detectable dose from laboratory measurements.
• Method Comparison: N = 56 patient samples. The data provenance (country of origin, retrospective/prospective) is not explicitly stated, but the mention of "patient samples" suggests retrospective or prospective clinical samples. It does not state if these were collected specifically for this study or were archived.
• Precision: 80 measurements for each of the three control levels over multiple runs/days. This refers to laboratory-controlled measurements of quality control materials.
• Interferences:
  • Endogenous Substances: N=2 or N=3 for each interferent tested. These were likely laboratory-prepared samples with added interferents, a prospective study.
  • Human Anti-Mouse Antibodies (HAMA): Not explicitly stated, but given as "Rep 1" and "Rep 2" for HAMA Type-1 and Type-2, suggesting laboratory-spiked samples.
  • Cross-reactants: No 'N' is listed, but various cross-reactant drugs were tested at specified concentrations. This would be a laboratory-controlled study.
  • Anticoagulants: Not explicitly stated, but likely laboratory-controlled comparison of serum and plasma samples, a prospective study.

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

This document describes the performance characteristics of an in-vitro diagnostic (IVD) device for measuring a drug concentration. The "ground truth" in this context is established by:

• Known Reference Values: For accuracy, linearity, and sensitivity, the ground truth is the spectroscopically pure USP traceable amikacin spiked into human serum at known concentrations.
• Reference Method: For method comparison, the ground truth is considered the results obtained from the predicate device, the Abbott TDx/TDxFLx® Amikacin assay.

Therefore, there were no clinical experts (e.g., radiologists) involved in establishing the "ground truth" in the way one would for image interpretation or diagnosis. The ground truth relies on analytical chemistry principles and a comparative reference method for this type of device.

4. Adjudication Method for the Test Set

Not applicable. This is an analytical device for quantitative measurement, not a human-interpreted diagnostic output requiring adjudication. The performance is assessed by comparing the device's output to known input concentrations or to measurements from a predicate device.

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

Not applicable. This is a standalone analytical device, not a human-in-the-loop system where human reader performance is being evaluated or augmented by AI.

6. Standalone (Algorithm Only) Performance

Yes, the studies presented here are entirely standalone performance evaluations of the QMS® Amikacin assay. The device measures amikacin concentration in a sample without human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the underlying chemical reaction and optical detection described in the "Description of Device," which is inherent to the device's operation.

7. Type of Ground Truth Used

• Known (Spiked) Concentrations: For accuracy, linearity, and sensitivity, the ground truth was established by precisely preparing samples with known concentrations of USP traceable amikacin.
• Reference Standard (Predicate Device): For method comparison, the Abbott TDx/TDxFLx® Amikacin assay served as the reference standard to which the new device's results were compared.

8. Sample Size for the Training Set

No information about a "training set" is provided. This is a traditional IVD device, not a machine learning or AI-driven system that would typically have a distinct "training set" and "test set" in the computational sense. The "development" and "validation" of the assay are implied by the studies conducted, but not in the context of training a machine learning model.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no dedicated "training set" is described for this type of device.

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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.

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

• Precision: 80 replicates for each of the three control levels (Low, Mid, High) over multiple runs and days.
• Accuracy: Triplicate measurements for 9 different theoretical concentrations.
• Linearity: Triplicate measurements for 5 different theoretical concentrations.
• Sensitivity: Determined using standard deviation of duplicate determinations of the zero calibrator and the 1st non-zero calibrator (Cal B, 5µg/mL).
• Specificity (CDP-I): Not explicitly stated, but implies a sufficient number of replicates to determine cross-reactivity percentage at a specified concentration.
• Interferences (Endogenous): Triplicate measurements for each of the 8 interfering substances tested.
• Interferences (HAMA): Triplicate measurements for HAMA Type-1, HAMA Type-2, and their respective controls.
• Interferences (Co-Administered Drugs): Not explicitly stated for each drug, but for all 44 drugs, measured at 500 µg/mL in a vancomycin spiked serum pool at 25 µg/mL, compared to a control serum.
• Interferences (Structurally Related Drug - Teicoplanin): Not explicitly stated, but implies sufficient measurements at 4 different teicoplanin concentrations.
• Method Comparison: 146 serum samples from patients.

Data Provenance: The document does not explicitly state the country of origin for any data or whether the studies were retrospective or prospective, beyond stating "human serum or plasma" for the intended use and "patient serum samples" for method comparison. Given the context of a 510(k) submission in the US, it's likely conducted or overseen in the US.

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

This device is an in-vitro diagnostic assay for measuring vancomycin concentration. The "ground truth" for the test set (e.g., actual vancomycin concentrations, absence/presence of interfering substances) would be established by the precise formulation of controls, calibrators, spiked samples, and highly accurate reference methods or laboratory standards, rather than expert human interpretation. For the method comparison study, the "ground truth" for the patient samples was established by the predicate device, the Abbott TDx® Vancomycin assay. Therefore, the concept of "experts establishing ground truth" in the typical sense of radiologists or pathologists is not directly applicable here.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation of medical images or clinical data where human readers might disagree. For an in-vitro diagnostic device that provides quantitative measurements, the "adjudication" is inherent in the analytical methods used to establish reference values (e.g., highly pure reference materials, established laboratory protocols, or a predicate device). No human expert adjudication was involved in generating the values used as "ground truth" for the performance studies presented.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. This type of study is designed to evaluate the impact of a new diagnostic tool on decisions or performance of human readers, typically in image interpretation. This is not relevant for a quantitative laboratory assay like QMS® Vancomycin, which provides a numerical output for drug concentration.

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

Yes, the studies presented are all standalone performance evaluations of the QMS® Vancomycin assay. The device directly measures vancomycin concentration in a sample, and the performance characteristics (precision, accuracy, sensitivity, specificity, interference, method comparison) are assessed based solely on its own analytical output. There is no "human-in-the-loop" interaction in the immediate result generation for a quantitative assay of this nature.

7. Type of Ground Truth Used

The ground truth used for various studies includes:

• Precision: Defined concentrations of vancomycin in control materials.
• Accuracy (Recovery): Known theoretical concentrations of USP traceable vancomycin spiked into human serum.
• Linearity (Dilution): Known theoretical concentrations of vancomycin prepared by dilution.
• Sensitivity: Relies on the statistical properties of measurements of a zero calibrator and a known low-concentration calibrator (Cal B at 5 µg/mL).
• Specificity & Interferences: Known concentrations of vancomycin, the metabolite CDP-I, various endogenous substances, HAMA, co-administered drugs, and teicoplanin, either alone or spiked into vancomycin-containing serum.
• Method Comparison: Results obtained from the predicate device, the Abbott TDx® Vancomycin assay, used as the reference method for patient serum samples.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development. For an immunoassay like QMS® Vancomycin, the development typically involves extensive characterization of reagents, optimization of assay parameters, and formulation of calibrators and controls. This process would involve numerous experiments and data points before the final performance studies (summarized here) are conducted to demonstrate suitability for market clearance. The data provided focuses solely on the validation/test performance of the finalized device.

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

As noted above, a formal "training set" as understood in machine learning (where an algorithm learns from data with established ground truth) is not directly applicable to the development of a homogeneous particle-enhanced turbidimetric immunoassay. Instead, the "ground truth" during development would be established through:

• Chemical and biological characterization of reagents: Ensuring the quality and specificity of antibodies and microparticles.
• Use of highly purified vancomycin standards (e.g., USP traceable): To prepare calibrators and to spike samples for recovery and linearity studies.
• Reference laboratory methods: Potentially used during early development to confirm the accuracy of initial assay designs or to validate the content of control materials.
• Industry standards and guidelines: Extensive experimentation guided by principles for developing accurate and precise quantitative immunoassays.

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The MULTIGENT™ Hb A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent Hb Alc (hemoglobin fraction) in human whole blood on the AEROSET® System and ARCHITECT® c8000™ System. The Hb A1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus. The MULTIGENT™ Hb A1c assay is not intended for use in diagnosing diabetes mellitus.

The MULTIGENT™ Ho A1c Calibrators are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for the calibration of the assays in the MULTIGENT™ Hb Alc Reagent Kit.

The MULTIGENT™ Ho Alc Controls are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for quality control of the assays in the MULTIGENTTM Hb A1c Reagent Kit.

The Device consists of the MULTIGENT™ Hemoglobin A 1 c Reagents, MULTIGENT™ Hemoglobin Alc Calibrators , and MULTIGENT™ Hemoglobin A 1 c Controls, intended for use on AEROSET® System and ARCHITECT® c8000™ System for determination of stable % HbAlc.

The assay consists of two separate concentration measurements, the stable form of glycated hemoglobin (Hb A 1 c) and the total hemoglobin (THb), which are used only to determine the percent Hb Alc. and must not be used individually for diagnostic purposes.

The whole blood specimen is pre-treated to lyse the erythrocytes. The hemoglobin is degraded by the proteolytic enzyme, pepsin, to form a hemolysate. Both the THb and the Hb A1c concentrations are determined from the same hemolysate.

The concentration of total hemoglobin is determined colorimetrically using a wavelength of 604 mm. The sample's measured absorbance is compared to a two-point calibration curve for total hemoglobin.

The concentration of stable Hb Alc is measured immunoturbidimetrically using a microparticle agglutination inhibition method. The Hb A1c antibody reagent (R1) contains specific anti-Hb A 1c mouse monoclonal antibodies coupled to microparticles. The Hb A1c agglutinator reagent (R2) contains several copies of the immunoreactive portion of Hb A1c (hapten), covalently bound to a polymer.

In the absence of Hb Alc in the sample, the hapten in the R2 reagent binds with the antibodycoated microparticles in the R1 antibody reagent and results in an increase in the rate of agglutination and results in an increase in measured absorbance. In the presence of HD A Ic in the sample, the Hb Alc competes with the hapten in the R2 reagent for binding sites on the antibody-coated microparticles in the R1 antibody reagent and will slow the rate of agglutination as it competes with the Hb Alc agglutinator for antibody binding sites.

The increase in concentration of Hb Alc in the sample is inversely proportional to the rate of agglutination and the measured absorbance. The absorbance is measured using a wavelength of 700 nm. The measured absorbance of the sample is compared to the measured absorbance of known Hb Alc concentrations (g/dL) of a six-level calibration curve, and the concentration of the sample is interpolated. The percent Hb A1c is the Hb A1c /THb ratio, calculated automatically by the AEROSET® System and ARCHITECT® c8000™ System, using a conversion factor to correlate the result with an NGSP-certified method.

The calibrators are supplied in liquid form and are ready to use without pretreatment. The controls are supplied in lyophilized form and are to be reconstituted with the supplied reconstitution fluid.

Here's a breakdown of the acceptance criteria and the study details for the Seradyn MULTIGENT™ Hemoglobin A1c device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Specificity and Interfering Substances: Specific concentrations of various interfering substances were used. The number of samples tested per substance is not explicitly stated, but the tests were performed "with the MULTIGENT™ Hb A1c assay." The provenance is not specified but is implicitly from laboratory testing.
   • Precision: "Whole blood samples" were used. The sample size for precision studies was n=80 (following NCCLS EP5-A protocol) for each of two concentration levels on both the AEROSET® System and ARCHITECT® c8000™ System. Data provenance is implicitly from laboratory testing, most likely in the USA where Seradyn Inc. is located.
   • Method Comparison: 117 "whole blood patient samples" were used. The provenance is not specified but is implicitly from laboratory testing, most likely in the USA.

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

   • This is a submission for an in-vitro diagnostic device (reagents and controls), not an imaging or diagnostic algorithm that relies on expert interpretation. Therefore, the concept of "experts establishing ground truth" in the traditional sense of clinical interpretations (e.g., radiologists) is not directly applicable.
   • The "ground truth" for the comparative studies is established by the predicate device, the Tosoh Medics Inc., G7 Automated HPLC Analyzer: HbA1c Variant Analysis Mode. This predicate device is a legally marketed device and its results are considered the reference for comparison.

3. Adjudication Method for the Test Set:

   • Not applicable. The study is a comparative analysis between the new device and a predicate device, and laboratory performance metrics. Human adjudication of results is not described or relevant for this type of device submission.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation by human readers, where AI might assist in improving their performance. This submission is for an in-vitro diagnostic instrument system, which automates the measurement process.

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

   • Yes, the performance data presented (linearity, specificity, precision, method comparison) reflects the standalone performance of the MULTIGENT™ Hb A1c assay on the AEROSET® System and ARCHITECT® c8000™ System. While human operators are involved in running the assay and handling samples, the measurement itself is automated by the device, and the reported performance characteristics are inherent to the assay and instrument.

6. The type of ground truth used:

   • For the comparative analysis, the results obtained from the legally marketed predicate device (Tosoh G7 Automated HPLC - Hb A1c Variant Analysis Mode) served as the ground truth or "reference method" for demonstrating substantial equivalence.
   • For other performance characteristics like linearity and precision, the ground truth is established through internal scientific validation against known standards and established protocols (e.g., NCCLS EP5-A).

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of machine learning. For an in-vitro diagnostic device of this nature, calibration curves are established using known concentrations of HbA1c calibrators, and internal validation is performed. The number of samples for developing these internal parameters is not specified, but the calibrators themselves are a "six-level calibration curve" (page 2).

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

   • Again, a "training set" in the AI/ML sense is not directly applicable. The "ground truth" for establishing the calibration and internal performance characteristics is based on:
     • Known concentrations of stable HbA1c in the MULTIGENT™ Hb A1c Calibrators. These calibrators are provided in liquid form and are used to create the six-level calibration curve for the assay.
     • Standardized protocols and materials for internal validation studies, such as the NCCLS EP5-A protocol for precision.

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