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The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients.
The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use.
The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.

Here's an analysis of the provided text to extract the requested information:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence rather than defining explicit acceptance criteria for a new clinical performance study. The core of the evidence relies on a split-sample comparison to demonstrate agreement with existing, validated methods.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 109 clinical samples
• Data Provenance: Clinical samples from kidney, heart, and liver transplant patients. The country of origin is not specified but is implied to be clinical data. The study is retrospective, as it involves a "split sample comparison" with existing methods, suggesting these samples were collected and then tested by both new and reference methods.

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

• This study does not involve "experts" in the traditional sense of clinicians or radiologists establishing ground truth. Instead, the ground truth is established by reference methods (HPLC/LC-MS assays). The qualifications of the personnel performing these reference assays are not detailed, but it's assumed they are trained laboratory professionals.

4. Adjudication Method for the Test Set

• There was no explicit "adjudication method" described as this was a quantitative comparison against established laboratory reference methods (HPLC/LC-MS). Discrepancies between the new device and the reference method would be analyzed through statistical comparison rather than a consensus process involving multiple human adjudicators.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test system, not an imaging or diagnostic AI system that would typically involve human readers. The performance is assessed by comparing quantitative results to a gold standard, not by evaluating human reader performance with or without AI assistance.

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

• Yes, the performance described is effectively "standalone" for the device, meaning it's the performance of the automated assay itself. There is no human-in-the-loop component in the measurement of mycophenolic acid by the Dimension® MPAT system. The device produces a quantitative result without human interpretation of the assay's execution, though a human would interpret the clinical significance of the numerical result.

7. The Type of Ground Truth Used

• Reference Method Assays: The ground truth was established by HPLC/LC-MS assays. These are considered gold standard methods for quantitative measurement of analytes like mycophenolic acid in clinical chemistry.

8. The Sample Size for the Training Set

• The document does not provide information regarding a separate "training set" or its size. For an IVD assay like this, the development process likely involves extensive internal optimization and verification using various samples, but these are generally not described as a distinct "training set" in the context of a 510(k) submission for an immunoassay. The presented data is for the validation of the finalized device.

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

• Since a specific "training set" is not detailed, this information is not provided. If such a phase existed, the ground truth would similarly be established by robust reference methods or gravimetric preparation of known concentration samples.

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The CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.

The CEDIA Mycophenolic Acid Calibrators are intended for use in the calibration of the CEDIA MPA Assay.

The MAS Mycophenolic Acid Controls are intended for use as assayed quality control material for validation of MPA assays.

The CEDIA Mycophenolic Acid Assay is a homogeneous assay based on the enzyme ()-galactosidase, which has been genetically engineered into two inactive fragments termed enzyme donor (ED) and enzyme acceptor (EA). These fragments spontaneously re-associate to form fully active enzymes that, in assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

The assay consists of a set of four reagents: Enzyme Acceptor Buffer, Enzyme Acceptor Reagent, Enzyme Donor Buffer, and Enzyme Donor Reagent. A two-level (Low and High) set of calibrators is used to calibrate the assay. A three-level set of controls (1 through 3) is used for quality control of the assay.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CEDIA Mycophenolic Acid Assay:

This submission is a 510(k) premarket notification for a new in vitro diagnostic (IVD) device, the CEDIA® Mycophenolic Acid Assay. The primary purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. Therefore, the "acceptance criteria" for this submission are not expressed as specific performance thresholds for sensitivity, specificity, etc., as one might find in an AI/software device submission for an imaging modality. Instead, the acceptance criteria are implicitly that the device performs comparably to the predicate device across various technological characteristics. The study presented is a "performance testing" to verify that the device functions as intended and that design specifications have been satisfied, in comparison to the predicate.

Here's the information as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an in vitro diagnostic device seeking substantial equivalence to a predicate, the "acceptance criteria" are the functional and performance characteristics of the predicate device that the new device aims to match or be comparable to. The reported "device performance" is how the new device measures up against those characteristics. The document doesn't provide specific quantitative acceptance ranges for parameters like analytical sensitivity or precision, but rather a direct comparison of the characteristics.

Conclusion on Acceptance: The document explicitly states: "As summarized, the CEDIA Mycophenolic Acid Assay is substantially equivalent to the Roche Total Mycophenolic Acid assay. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." This indicates that the device met the implicit acceptance criteria of being comparable to the predicate for the purpose of a 510(k) clearance.

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

The provided text does not explicitly state the sample size used for the performance testing (test set) or the data provenance (e.g., country of origin, retrospective or prospective). For IVD devices, such studies would typically involve a certain number of patient samples, but this detail is not present in the summary.

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

This information is not applicable and therefore not provided in the document. For an IVD assay measuring a chemical compound (mycophenolic acid), the "ground truth" is typically established by reference methods (e.g., mass spectrometry, HPLC) or by the performance of the predicate device itself, not by expert human graders or clinicians evaluating images.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods like 2+1 or 3+1 are relevant for tasks involving subjective human interpretation (e.g., radiology reads), which is not the case for a quantitative chemical assay.

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 relevant for imaging devices where multiple human readers interpret cases. For an IVD assay, the comparison is directly between the new assay's quantitative results and those of a predicate device or reference method.

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

The device itself is a standalone algorithm/assay in the context of its function, meaning it directly measures mycophenolic acid concentration. The performance testing outlined in the 510(k) (though not detailed here) would be analogous to a "standalone" evaluation of the assay's accuracy, precision, linearity, and other analytical performance characteristics against established laboratory standards or the predicate device. There is no human "in-the-loop" for the measurement process itself, although clinicians use the results in patient management.

7. The Type of Ground Truth Used

The "ground truth" for this type of IVD device is generally established by:

• Comparison to a legally marketed predicate device: The new device's results are compared to the predicate device's results using patient samples.
• Analytical performance studies: This involves assessing parameters like accuracy (recovery), precision (reproducibility), linearity, limit of detection, and interference studies against known standards or reference materials.
• In some cases for quantitative assays, reference methods (e.g., mass spectrometry, HPLC) are considered the "gold standard" for establishing true values.

The provided summary emphasizes substantial equivalence to the predicate device based on "performance testing," suggesting the predicate's results served as a primary reference for comparison.

8. The Sample Size for the Training Set

The provided text does not state the sample size for any "training set." For a traditional IVD assay like this, there isn't typically a "training set" in the machine learning sense. The assay is developed and optimized, and then its performance is validated in studies. If any statistical models or thresholds were optimized during development, those would involve internal R&D data, not a formally defined "training set" as understood in AI/ML contexts.

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

As there's no explicitly defined "training set" in the AI/ML sense, this information is not applicable and not provided. The development of the assay would have involved standard chemical and biochemical experimentation with known concentrations of mycophenolic acid and other substances to optimize the reagent formulations and reaction conditions.

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