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The CSA method is an in vitro diagnostic test for the quantitative measurement of Cyclosporine A (CSA) in human whole blood on the Dimension Vista™ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
The Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device intended to quantitatively determine cyclosporine concentrations in human whole blood. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients receiving therapy with this drug.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Cyclosporine (CSA) Flex® reagent cartridge (K023065), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system. The reagents contained in the Dimension Vista™ CSA Flex® reagent cartridges are the same as those contained in the CSA Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the device, nor does it alter the fundamental scientific technology of the device.

The provided text describes a 510(k) Special submission for a packaging modification of a device, the Dimension Vista™ Cyclosporine (CSA) Flex® reagent cartridge. This submission is primarily about demonstrating that the modified device (for use on the Dimension Vista™ system) is substantially equivalent to an existing predicate device (the Dimension® Cyclosporine (CSA) Flex® reagent cartridge, K023065).

The information provided focuses on the comparison between the new device and the predicate device, rather than a detailed study proving the new device's performance against specific acceptance criteria. The core of the submission is that the reagents and fundamental scientific technology are the same, and the packaging change does not affect its intended use.

Therefore, the study supporting this submission is not a typical clinical trial with detailed performance metrics against a defined ground truth, but rather a comparative study demonstrating substantial equivalence based on the device's characteristics and functionality.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this context are not explicitly stated as numerical performance targets (e.g., specific sensitivity/specificity values). Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device. This means showing that the new device performs comparably to the predicate device and that any differences do not raise new questions of safety or effectiveness.

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

The document does not explicitly state the sample size used for any specific testing to demonstrate substantial equivalence, nor does it specify data provenance (country of origin, retrospective/prospective). Given that this is a Special 510(k) for a packaging modification with the same reagents, the focus would likely be on analytical performance aspects (e.g., precision, accuracy using control materials or spiked samples) rather than a large-scale clinical study with patient samples. The only stated change with a potential impact on sample requirements is the "Sample Size" of 1.9 µL for the new device vs. 5 µL for the predicate. This would require validation that the reduced sample volume does not compromise performance.

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

Not applicable for this type of submission. The ground truth for in vitro diagnostic devices like this is typically established by reference methods or validated control materials, not expert consensus in the way a diagnostic imaging device might use radiologists.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the validation focuses on analytical performance characteristics of the assay rather than a subjective interpretation needing expert adjudication.

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 reagent cartridge; it does not involve human readers or AI in the context of interpretation of medical images or other clinical data.

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

The device itself is a standalone assay system once integrated onto the Dimension Vista™ analyzer. Performance is measured by the accuracy and precision of the quantitative cyclosporine measurement. The "study" mentioned here is the comparison to the predicate device to demonstrate substantial equivalence, which would involve assessing the quantitative output of the device.

7. The Type of Ground Truth Used

The ground truth for this type of in vitro diagnostic quantitative assay would typically be established using:

• Reference materials/calibrators: Materials with a known, accurately assigned concentration of cyclosporine.
• Split samples: Comparing results from the new device with results from the predicate device (or another validated method) on the same patient samples.
• Spiked samples: Samples (e.g., whole blood matrix) to which a known amount of cyclosporine has been added, allowing for recovery studies.

The document does not specify the exact type of ground truth used, but these are standard practices for IVD validation.

8. The Sample Size for the Training Set

Not applicable. This device is a reagent cartridge for a quantitative assay; it does not employ machine learning or AI models that require a "training set" in the conventional sense. Its performance is based on the chemical reactions and optical measurement principles of the assay.

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

Not applicable, as there is no training set for this type of device.

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The CSA Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) in human whole blood for the Dimension® clinical chemistry system. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients.

The automated Dimension® CSA method uses an immunoassay technique in which free and CSA-bound antibody-enzyme species are separated using magnetic particles. Following separation, the CSA-antibody-enzyme complex is mixed with the substrate. Bgalactosidase catalyzes the hydrolysis of CPRG (chlorophenol red ß-d- galactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577 nm. The change in absorbance at 577 nm due to the formation of CPR is directly proportional to the amount of CSA in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique.

The provided text describes the summary of safety and effectiveness information for the Dade Behring Inc. Cyclosporine (CSA) Flex® reagent cartridge. It primarily focuses on demonstrating substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a typical quantitative framework (e.g., "correlation coefficient must be > 0.90"). Instead, it presents a comparison to a predicate device and then reports the performance of the new device against that predicate, implying that the reported values met the implicit criteria for substantial equivalence.

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

• Sample Size: 667 clinical patient samples
• Data Provenance: The data is described as "clinical patient samples," suggesting it's from human subjects. The country of origin is not specified but is implicitly within the region where Dade Behring Inc. operates (Newark, DE, USA). The study appears to be retrospective in nature as it involved collecting and testing existing clinical samples to compare the two methods.

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

The document does not explicitly mention the use of experts to establish ground truth for this specific comparison study. The comparison is between two quantitative diagnostic assays (the investigational device, CSA Flex®, and the predicate device, Abbott TDx® CSA). In such cases, the "ground truth" for the comparison is typically the result from the established predicate method or a reference method.

4. Adjudication Method for the Test Set

Not applicable. This was a direct comparison study between two quantitative methods, not a study requiring expert adjudication of qualitative interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance

Not applicable. This is an in vitro diagnostic device for quantitative measurement of cyclosporine A, not an imaging or diagnostic interpretation device that involves human readers or AI assistance in interpretation.

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

Yes, the study described is a standalone performance comparison. The CSA Flex® reagent cartridge on the Dimension® clinical chemistry system is a device that provides quantitative measurements. The comparison was directly between the quantitative results of the CSA Flex® and the predicate TDx® CSA assay, without human intervention in the result generation or interpretation that would change the quantitative output.

7. The Type of Ground Truth Used

The ground truth used for this comparison study was the results obtained from the predicate device, the Abbott TDx® Cyclosporine Monoclonal Whole Blood Assay. The study essentially compared the new device's performance against an established and legally marketed device.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" for the CSA Flex® reagent cartridge. This type of FDA submission (510(k) for an in vitro diagnostic assay) typically focuses on performance validation rather than machine learning model training as understood in AI/ML contexts. The device's development would involve internal validation and optimization, but distinct "training set" reporting as might be found for AI models is not present here.

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

As no specific "training set" is mentioned in the context of machine learning for this device, the method for establishing its ground truth is not detailed. For chemical assays, the development process generally involves optimizing reagents and protocols against known standards and reference materials, rather than a labeled training dataset of patient samples.

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