(125 days)
The Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients.
The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay and/or the Emit® 2000 Tacrolimus Assay.
The Emit® 2000 Sirolimus Calibrators are intended for use in the calibration of the Emit® 2000 Sirolimus Assay.
The Emit® 2000 Sirolimus Assay is for in vitro diagnostic use for the quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients. The Emit® 2000 Sirolimus 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 sirolimus.
The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay. The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Sirolimus Assay. The pretreatment process lyses the cells, extracts the sirolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing sirolimus is then assayed using the Emit® 2000 Sirolimus Assay.
The Emit® 2000 Sirolimus Calibrators are frozen material containing sirolimus in preserved whole blood hemolysate. There are six (6) calibrator levels containing 0, 3, 6, 12, 24 and 36 ng/mL.
Here's a breakdown of the acceptance criteria and study information for the Emit® 2000 Sirolimus Assay, Emit® 2000 Siro/Tacro Sample Pretreatment Reagent, and Emit® 2000 Sirolimus Calibrator, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Emit® 2000 Sirolimus Assay vs. LC/MS/MS) |
|---|---|
| Method Comparison | Slope: 1.30 ng/mL |
| Intercept: 0.054 | |
| Correlation Coefficient (r): 0.946 |
Note: The document does not explicitly state pre-defined acceptance criteria values for slope, intercept, or correlation coefficient. However, the reported values are presented as the "result" of the study, implying they met the internal criteria for substantial equivalence to the predicate device and the reference method (LC/MS/MS).
2. Sample Size and Data Provenance
- Test Set Sample Size: 128 samples
- Data Provenance: Samples were from kidney transplant patients and were collected from two external sites. The document does not specify the country of origin, but it implies a clinical setting.
- Retrospective or Prospective: The document does not explicitly state whether the study was retrospective or prospective. Given that samples from kidney transplant patients were used and compared against LC/MS/MS, it is likely a retrospective analysis of existing patient samples where Sirolimus levels were measured by both methods, or a prospective collection for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth
The concept of "experts" to establish ground truth in the context of diagnostic assay comparison is typically applied when the ground truth is subjective (e.g., image interpretation). For this device, which measures a quantitative analyte (Sirolimus), the ground truth is established by a reference method (LC/MS/MS), not by human experts interpreting results. Therefore, this section is not directly applicable in the way it would be for, say, a radiology AI device.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth was established by LC/MS/MS, a laboratory reference method, not by human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted or described. This type of study focuses on comparing the diagnostic performance of human readers, with and without AI assistance, on multiple cases. The Emit® 2000 Sirolimus Assay is a standalone in vitro diagnostic device, not an AI-assisted interpretation system for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The method comparison study directly evaluated the performance of the Emit® 2000 Sirolimus Assay against the LC/MS/MS reference method. This assesses the algorithm's (assay's) performance without human-in-the-loop interaction for result generation, although human operators perform the assay.
7. Type of Ground Truth Used
The type of ground truth used was comparison to a reference method: Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS). LC/MS/MS is considered a "gold standard" or highly accurate method for quantifying Sirolimus in biological samples.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This is a common characteristic of traditional in vitro diagnostic assays, which are developed and validated through analytical studies and method comparisons, rather than "trained" in the machine learning sense. The assay relies on specific reagents (antibodies, enzymes) designed for Sirolimus detection.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no distinct "training set" in the machine learning context is mentioned or implied for this device. The development and optimization of such assays typically involve extensive analytical studies using characterized samples, but these are not referred to as a "training set" with ground truth established in the same manner as for AI/ML algorithms.
§ 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.