(51 days)
The Emit® 2000 Tacrolimus Assay is for in vitro quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients.
The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay.
The Emit® 2000 Tacrolimus Assay is for in vitro diagnostic use for the quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients. The Emit® 2000 Tacrolimus Assay is comprised of an antibody reagent, a buffer reagent and an enzyme reagent. This assay contains mouse monoclonal antibodies with a high specificity for tacrolimus.
The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay. The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Tacrolimus Assay. The pretreatment process lyses the cells, extracts the tacrolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing tacrolimus is then assayed using the Emit® 2000 Tacrolimus Assay.
The provided document K060385 describes the Emit® 2000 Tacrolimus Assay and its associated Sample Pretreatment Reagent. The study presented compares the performance of this new assay against two established methods: Liquid Chromatography/Mass Spectrometry (LC/MS) and the Abbott IMx® Tacrolimus II Assay.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., a specific minimum slope and correlation coefficient). Instead, it presents the results of method comparison studies and implies that these results demonstrate substantial equivalence to the predicate devices. The "reported device performance" refers to the results obtained from these comparison studies.
| Comparative Method | Reported Performance Metric | Value (All samples) |
|---|---|---|
| LC/MS/MS | Slope | 1.15 |
| Intercept | -0.33 | |
| R-value (Correlation) | 0.940 | |
| Abbott IMx® Tacrolimus II | Slope | 0.92 |
| Intercept | -0.04 | |
| R-value (Correlation) | 0.881 |
Note: Since explicit acceptance criteria are not provided, the "acceptance criteria" column is implicitly an expectation of strong correlation and a slope/intercept close to 1 and 0 respectively for substantial equivalence, which the reported performance aims to demonstrate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For comparison against LC/MS/MS: 197 samples (All samples)
- For comparison against Abbott IMx® Tacrolimus II Assay: 192 samples (All samples)
- Data Provenance: The samples were from "2 transplant groups (liver and kidney)". The studies were "conducted at two external sites". This indicates the data is prospective or at least gathered specifically for this study, and likely from a clinical setting. The country of origin is not explicitly stated, but given the manufacturer (Dade Behring Inc., US-based) and the FDA submission, it is likely the data was collected in the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For methods like LC/MS/MS, the "ground truth" is typically defined by the analytical method itself rather than human expert interpretation of results, as it is considered a highly accurate and precise reference method.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods are typically relevant for studies where human interpretation of data (e.g., images) forms the ground truth or is being evaluated for consistency. In this case, the comparisons are against established quantitative analytical methods (LC/MS/MS and a predicate immunoassay), where the result is a numerical value directly from the instrument.
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 evaluating the impact of an AI system on human interpretation of medical images or other data. The Emit® 2000 Tacrolimus Assay is an in vitro diagnostic test that provides a quantitative result directly, not a system designed for human-in-the-loop assistance for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The entire study focuses on the "algorithm only" (the Emit® 2000 Tacrolimus Assay) performance by comparing its quantitative output to other analytical methods. The device provides a direct numerical result without human interpretation being part of its core function or an evaluated human-in-the-loop workflow.
7. The Type of Ground Truth Used
The ground truth used for comparison was established by:
- Liquid Chromatography/Mass Spectrometry (LC/MS/MS): This is a highly accurate and precise analytical method often considered the gold standard for quantitative measurements of tacrolimus.
- Abbott IMx® Tacrolimus II Assay: This is a legally marketed predicate device, recognized as an established method for tacrolimus testing.
8. The Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. Immunoassays like the Emit® 2000 Tacrolimus Assay are developed through chemical and biological engineering, not typically 'trained' in the same way machine learning algorithms are. The provided data represents validation against existing methods.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for this type of IVD device, this information is not applicable/provided. The ground truth for validation was established by LC/MS/MS and the predicate device.
§ 862.1678 Tacrolimus test system.
(a)
Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus 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 tacrolimus.(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.