(19 days)
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.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Reagents | Same as predicate device | "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." |
| Intended Use | Same as predicate device | "in vitro diagnostic use." "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." |
| Indications for Use | Same as predicate device | "Same as Dimension® analyzer" and "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." |
| Tablet Sizes | Same as predicate device | 7/32" |
| Total tests/cartridge | Same as predicate device | 20 |
| Calibration | Same as predicate device | 30 days |
| Sample Type | Same as predicate device | whole blood |
| Reportable Range | Same as predicate device | 25 - 500 ng/mL |
| Sample Size | Acceptable and demonstrated not to negatively impact performance (despite difference) | 1.9 µL (predicate is 5 µL - this is a key difference) |
| Measurement Method | Same as predicate device | Bichromatic rate @ 577 & 700 nm |
| Packaging modification | Does not affect intended use or alter fundamental scientific technology | "The packaging modification, does not affect the intended use of the device, nor does it alter the fundamental scientific technology of the device." |
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.
§ 862.1235 Cyclosporine test system.
(a)
Identification. A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.