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510(k) Data Aggregation
(212 days)
The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
The IMx® Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx® Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood.
The IMx Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMx® Sirolimus Calibrators and Controls) to be tested on the IMx® Sirolimus assay.
Microparticle Enzyme Immunoassay (MEIA) for use on Abbott IMx® system.
Assay procedure:
- Incubate the sample with the anti-sirolimus antibody-coated microparticles.
- Add sirolimus alkaline phosphatase conjugate and incubate.
- Transfer to matrix cell.
- Wash to remove unbound substances.
- Add substrate.
- Measure fluorescent product.
This document describes the performance characteristics and acceptance criteria for the Abbott IMx® Sirolimus Microparticle Enzyme Immunoassay (MEIA) test.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate device or implied by comparison) | Reported Device Performance (IMx® Sirolimus MEIA Test) |
|---|---|---|
| Precision | Within-run CV of 2.2 - 7.0%; Between-run CV of 2.2 - 9.2% (CEDIA® Sirolimus Test) | Total imprecision of ≤ 15% through assay range of 5-22ng/ml |
| Recovery | Recovery of 101 - 112% of expected values (CEDIA® Sirolimus Test) | Mean recovery across samples of 90 - 110% of expected values. |
| Dilution Linearity | Recovery of 91 - 106% of expected values for a single high sample (CEDIA® Sirolimus Test) | Mean recovery across samples of 99 - 115% of expected values. |
| Analytical Sensitivity | 4.0 ng/mL (CEDIA® Sirolimus Test) | ≤ 1.5ng/ml |
| Functional Sensitivity | Not listed (CEDIA® Sirolimus Test) | ≤ 2.5ng/ml |
| Specificity for Parent Compound (Cross-reactivity with metabolites) | 11-hydroxy - 44%; 41-O- and 32-O-Demethyl - 73%; Trihydroxy and 41-O-didemethyl - 14%; 41-desmethyl-hydroxy- 10%; Fraction 2 and 7-O-desmethyl - 8.7%; Isomers of fraction 4 - 22%; Hydroxyl - 7%; N-oxide - 15%; Fraction 6 and isomers of Fraction 7 - 4% (CEDIA® Sirolimus Test) | 11-hydroxy-sirolimus - 37%; 41-O-demethyl-sirolimus - 58%; 7-O-demethyl-sirolimus - 63%; 41-O-demethyl-hydroxyl-sirolimus - 6% |
| Co-Administered Drug Interference | <0.015% cross-reactivity for 42 drugs; Cyclosporine at 10,000ng/ml, Tacrolimus at 300ng/ml, Mycophenolic Acid at 100,000ng/ml (Tacrolimus showed 0.4% cross-reactivity, others <0.015%) (CEDIA® Sirolimus Test) | 62 drugs tested; Gemfibrozil (75µg/ml), Itraconazole (10.5µg/ml), MPAG (1800µg/ml), OKT3(6.0µg/ml), Trimethoprim (40µg/ml) showed between 10% and 15% apparent interference with Medium Control. |
| Interference from Endogenous Compounds | No significant interference from: Unconjugated bilirubin up to 60mg/dl, Cholesterol up to 500mg/dl, Triglycerides up to 1500mg/dl, Rheumatoid Factor up to 573IU/ml, Protein (albumin) up to 11g/dl, Protein (gamma globulin) up to 4.9g/dl, Haematocrit levels between 20 – 60% (CEDIA® Sirolimus Test) | < 10% interference at levels: Bilirubin - 0.4mg/ml, Cholesterol - 5mg/ml, Triglycerides - 10mg/ml, Uric Acid - 0.2mg/ml, Rheumatoid Factor - 500IU/ml, Protein (Albumin) – 3-12g/dl, Protein (Gamma Globulin) - 3-12g/dl, HAMA - 60ng/ml; Haematocrit levels between 15-60% produced <25% interference. |
| Sample Storage Stability | 1 week at 2-8°C and 2 years at -70°C (CEDIA® Sirolimus Test) | Specimens collected in EDTA tubes may be stored for up to 28 days at 2-8°C or -20°C prior to being tested. Repeated freezing and thawing (more than 3 freeze-thaw cycles) should be avoided. |
Study Proving Device Meets Acceptance Criteria:
The document describes a 510(k) Pre-market Notification for the IMx® Sirolimus Microparticle Enzyme Immunoassay. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Microgenics CEDIA® Sirolimus Assay (K034069), and also includes a comparison to the current accepted reference method for sirolimus measurement, High Performance Liquid Chromatography-tandem Mass Spectrometry (HPLC/MS/MS).
The "acceptance criteria" are implied by the comparison to the predicate device's performance characteristics, and the IMx® Sirolimus MEIA Test reports its own performance to show it is comparable or superior. The comparison to HPLC/MS/MS provides further evidence of the device's accuracy.
2. Sample Size Used for the Test Set and Data Provenance
-
Comparison to HPLC/MS/MS Method (Analytical Test Set):
- Sample Size: 221 samples ("n").
- Data Provenance: Not explicitly stated, but the study involved "All Sites," suggesting a multi-center study. The document is from Axis-Shield Diagnostics Ltd. in Scotland, UK, but the origin of the patient samples is not specified as domestic or international, nor if they were retrospective or prospective. It is likely that these were prospective samples collected specifically for method comparison, but this is an inference.
-
Performance Characteristics Comparison (IMx vs. CEDIA):
- The sample sizes for individual performance parameters (Precision, Recovery, Linearity, etc.) for the IMx® Sirolimus MEIA Test are not explicitly stated in the provided text. The results are reported as summary statistics (e.g., "Total imprecision of ≤ 15%", "Mean recovery across samples").
- Data Provenance: Not explicitly stated for these individual studies, but presumably conducted by Axis-Shield Diagnostics Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For the HPLC/MS/MS comparison: The ground truth is established by the HPLC/MS/MS method itself, which is described as the "current Device accepted reference method for sirolimus measurement." This is an instrumental method, not based on human expert consensus. Therefore, the concept of "experts used to establish ground truth" does not apply in the traditional sense for this part of the study.
- For other performance characteristics: The ground truth for determining precision, recovery, linearity, sensitivity, specificity, and interference in laboratory assays is typically established by the inherent properties of the reference materials and methods used in the testing, not by expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. This study is for an in vitro diagnostic (IVD) quantitative assay. Adjudication methods (like 2+1 or 3+1) are typically used in imaging studies or clinical trials where human interpretation of data is subjective and requires consensus. For an IVD assay, performance is quantitatively measured against a reference method or known values, not adjudicated by experts in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is an in vitro diagnostic (IVD) device, not an imaging or interpretive device that would typically involve a multi-reader multi-case study with human readers. The device provides a quantitative measurement, not an interpretation of a complex input that human readers would evaluate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is a standalone performance study. The document describes the performance of the IMx® Sirolimus Microparticle Enzyme Immunoassay (MEIA) test itself, as an automated system on the Abbott IMx® analyser. The results reported are directly from the device's measurement. While a human operates the device and interprets the numerical output in a clinical context, the performance characteristics detailed here (precision, sensitivity, comparison to HPLC/MS/MS) are inherent to the assay and instrument itself, without "human-in-the-loop" influencing the reported measurement accuracy or precision for these specific studies.
7. The Type of Ground Truth Used
- Instrumental Reference Method: For the direct comparison study, the ground truth was the High Performance Liquid Chromatography-tandem Mass Spectrometry (HPLC/MS/MS) method, described as the "current Device accepted reference method for sirolimus measurement."
- Known Reference Values/Spiked Samples: For parameters like Precision, Recovery, Dilution Linearity, Analytical Sensitivity, Specificity, and Interference, the ground truth is established using samples with known concentrations of sirolimus, its metabolites, or interfering substances. These known values act as the "ground truth" against which the device's measurements are compared.
8. The Sample Size for the Training Set
- The document describes a 510(k) submission for a finished IVD product, not a deep learning or AI model that typically has a separate "training set." The IMx® Sirolimus assay is an established technology (Microparticle Enzyme Immunoassay - MEIA).
- Therefore, the concept of a "training set" in the context of machine learning is not applicable to this type of device. The development and optimization of such an assay would involve internal R&D studies, but these are not referred to as "training sets" in the same way.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained above, there is no "training set" in the machine learning sense for this device. The development process would have involved rigorous analytical testing using reference materials and calibrated instruments to establish assay parameters, but not a "ground truth for a training set" as it would be understood for an AI algorithm.
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