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The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Serum or plasma is mixed with Reagent 1, which contains vancomycin labeled with the enzyme glucose-6-phosphate dehydrogenase (G6)DH). Subsequently, Reagent 2, which contains antibodies to vancomvcin and the coenzyme nicotinamide adenine dinucleotide (NAD), is added. Vancomycin in the sample and vancomycin-labeled G6PDH compete for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the vancomycin concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized NAD to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

Here's a breakdown of the acceptance criteria and the study details for the Dade Behring Inc. Emit® 2000 Vancomycin Assay, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria themselves are implied by the comparison to the predicate device. The stated performance metrics of the Emit® 2000 Vancomycin Assay in comparison to the predicate exceed typical internal acceptance thresholds for linearity and correlation in quantitative assays (e.g., correlation coefficient often expected to be >0.95 or >0.98, slope close to 1, and intercept close to 0).

Study Details

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

   • Sample Size: 100 patient samples
   • Data Provenance: Not explicitly stated, but the context of "patient samples" implies human biological samples. It's retrospective as it's a split sample comparison to an existing predicate.

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

   • This information is not provided. The ground truth for this type of assay comparison is established by the measurements obtained from the predicate device (Emit® Vancomycin Assay, K881040), which itself would have undergone its own validation.

3. Adjudication method for the test set:

   • Not applicable. This is a technical comparison of an in-vitro diagnostic device's quantitative output against a predicate device, not a diagnostic decision based on expert review.

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

   • Not applicable. This is not an AI-assisted diagnostic imaging or interpretation device. It's a quantitative chemical assay.

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

   • This study is a standalone performance evaluation of the Emit® 2000 Vancomycin Assay directly compared to a legally marketed predicate device. The assay itself operates without human intervention in the result generation, only in sample preparation and loading.

6. The type of ground truth used:

   • The ground truth for this comparison study was established by the measurements obtained from the predicate device (Emit® Vancomycin Assay, K881040). The predicate device's performance characteristics served as the reference standard. The samples ranged from 5 to 50 µg/dL.

7. The sample size for the training set:

   • Information on a separate "training set" is not provided as this is a traditional chemical assay validation for substantial equivalence, not a machine learning model. The development of the assay itself would have involved extensive R&D and optimization, but those details are not part of this 510(k) summary.

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

   • Not applicable, as a distinct training set (in the context of machine learning) is not described. The assay's analytical performance is based on its chemical and enzymatic reactions, which were developed and characterized to accurately measure vancomycin concentration.

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The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

Emit® 2000 Vancomycin Calibrators are liquid, six-level calibrators prepared from vancomycin, buffer and preservatives. The calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

The provided text describes information about a medical device, the "Emit® 2000 Vancomycin Calibrators," and its 510(k) submission. However, it does not contain the detailed performance study information typically associated with acceptance criteria and a study proving a device meets those criteria for image-based diagnostic AI/ML products.

This document describes a calibrator device, which is used to calibrate an assay, rather than a diagnostic AI/ML system that directly analyzes data for diagnosis. The performance characteristics described are related to the stability and manufacturing consistency of the calibrator itself, not the diagnostic performance of an AI system.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or not provided in the context of this device.

Here's an attempt to extract relevant information and note what is unavailable:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • For Shelf Life Stability: "at least 3 lots of calibrators" were used, stored at 9°C with comparison to calibrator sets stored at -20°C. Data provenance is implied to be internal testing by Dade Behring Inc. (retrospective data from real-time monitoring).
   • For Preparation / Lot Consistency: "20 replicates at each calibrator level" were tested for each new calibrator lot. Data provenance is implied to be internal manufacturing quality control by Dade Behring Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a calibrator, not a diagnostic device requiring expert interpretation of medical data. The "ground truth" for calibrators relates to their accurate concentration and stability.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML-based diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this calibrator device is based on "standard gravimetric procedures" to prepare the calibrators with known vancomycin concentrations and then comparing the lot's response to a "Master Lot" for consistency.

7. The sample size for the training set: Not applicable in the context of an AI/ML training set. The descriptions relate to manufacturing and stability testing procedures.

8. How the ground truth for the training set was established: Not applicable.

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