(378 days)
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.
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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
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Dimension® MPAT vs. Reference) |
|---|---|---|
| Correlation Coefficient (r) | High correlation (e.g., > 0.95 or 0.98) between new device and reference methods | 0.98 |
| Slope | Close to 1.0 (indicating proportional agreement) | 1.04 |
| Intercept (µg/mL) | Close to 0 (indicating minimal systematic bias) | -0.02 |
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.
§ 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.