(247 days)
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.
| Characteristic | Acceptance Criteria (Predicate Device - Roche Mycophenolic Acid Assay) | Reported Device Performance (CEDIA Mycophenolic Acid Assay) |
|---|---|---|
| Intended Use | Quantitative determination for total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients. | 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. |
| Test Principle | Enzyme-mimicking assay with MPA concentration inversely proportional to the assay signal (absorbance change). | Enzyme immunoassay with MPA concentration directly proportional to the assay signal (absorbance change). |
| Matrix | Non-hemolyzed human serum or plasma | Human plasma |
| Reagents | Two reagent assay | Two reagent assay |
| Calibrators | Six levels (0, 1, 3, 5, 10, 15 µg/mL) | Two levels (0 and 10 µg/mL) |
| Controls | Liquid serum-based (0.86, 3.40, 11.96 µg/mL) | Liquid plasma-based (1.0, 2.5, 6.0 µg/mL) |
| Assay Range | 0.4 to 15 ug/mL | 0.2 to 10.0 µg/mL |
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.
§ 862.3840 Sirolimus test system.
(a)
Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.