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510(k) Data Aggregation
(251 days)
The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
The ARCHITECT i Vancomycin assay is a device for the quantitative measurement of vancomycin in human serum or plasma. The device is a chemiluminescent microparticle immunoassay (CMIA) for in vitro diagnostic use, intended to aid in the diagnosis and treatment of vancomycin overdose and in monitoring its levels to ensure appropriate therapy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Total run %CV ≤ 10% | Total run %CV was ≤ 10% |
| Recovery | Not explicitly stated, but implied to be near 100% and within a reasonable range. | Overall percent recovery was 100.2%. Ranged from 98.0% to 105.4% for 5-45 ug/mL, and 86.4% for 3.2 µg/mL. |
| Interferences | Not explicitly stated, but implied that substances should not significantly impact recovery. | The mean recovery ranged from 93.0% to 104.5% for supplemented samples within specific interfering concentrations. |
| Linearity | Not explicitly stated, but implied to demonstrate a linear range across the assay's intended use. | Established linear range of 3.0 ug/mL to 50.0 ug/mL. |
| Sensitivity | Not explicitly stated, but values for LoB, LoD, and LoQ are provided. | Limit of Blank (LoB) was 0.27 ug/mL. Limit of Detection (LoD) was 0.42 ug/mL. Limit of Quantitation (LoQ) was 2.50 ug/mL. |
| Matrix Comparison | Not explicitly stated, but verified for various human serum and plasma types. | Verified for human serum and human plasma collected in Lithium heparin, Dipotassium EDTA, Sodium Citrate, Sodium Heparin, and Sodium Fluoride/Potassium Oxalate. |
| Specificity (Cross-reactivity) | Different criteria for CDP-1 (less than 0.42 µg/mL in absence of vancomycin, but interferes > 5 µg/mL in measurement range) and other compounds (less than 0.42 µg/mL for cross-reactivity, 100±10% recovery for interference). | CDP-1 at 10 ug/mL showed cross-reactivity < 0.42 µg/mL in the absence of vancomycin. CDP-1 at > 5 µg/mL interferes with samples containing vancomycin in the measurement range. Isoniazid at > 300 ug/mL interferes with samples containing vancomycin in the measurement range. Other tested compounds showed cross-reactivity < 0.42 µg/mL and no interference (100 ± 10% recovery). |
| Method Comparison (Correlation with predicate) | Not explicitly stated, but implied strong correlation (e.g., r close to 1, slope close to 1, intercept close to 0). | Correlation Coefficient (r) = 0.99 (95% CI: 0.99, 0.99). Slope = 1.04 (95% CI: 1.01, 1.07). Intercept = -0.23 (95% CI: -0.87, 0.36). |
| Measuring Interval | Not explicitly stated, but a defined range is established. | Measuring interval range: 3.0 µg/mL to 50.0 µg/mL. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision: The document states that "Vancomycin samples were tested for precision." It does not specify the exact sample size.
- Recovery: "Serum samples were spiked with vancomycin at concentrations across the assay range." The exact number of samples is not provided.
- Interferences: "Serum specimens with vancomycin levels from 4.4 to 48.8 µg/mL were supplemented with the following potentially interfering compounds." The exact number of specimens or replicates is not provided.
- Linearity: "Samples were tested to demonstrate linearity." The exact number of samples is not provided.
- Sensitivity: "In this study," no specific sample size is mentioned.
- Matrix Comparison: Specific number of samples or details on how many of each type of matrix were tested are not provided.
- Specificity: Specific numbers of samples for each compound tested are not provided.
- Method Comparison: 107 observations were used for the method comparison study between the new and predicate devices.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the nature of in vitro diagnostic device testing for regulatory submission, it is typically conducted prospectively at controlled laboratory sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (in vitro diagnostic for quantitative measurement) does not typically rely on human expert interpretation to establish ground truth for performance studies like precision, recovery, linearity, and interference. Instead, the "ground truth" for these studies is established through:
- Known concentrations: For studies like recovery and linearity, samples are spiked with known, precise concentrations of vancomycin or its analogues.
- Reference methods/predicate devices: For method comparison, the "ground truth" for the test samples is derived from measurements by a legally marketed predicate device (ARCHITECT i Vancomycin [LN 1P30-25] in this case) or a traceable reference method.
Therefore, there were no "experts" in the sense of radiologists or pathologists to establish ground truth for this device's performance characteristics.
4. Adjudication Method for the Test Set
Not applicable for this type of quantitative in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human readers interpret results and consensus is needed to establish ground truth or resolve discrepancies. Here, the measurements are quantitative chemical analyses performed by an automated system.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic device for quantitative chemical measurement, not an AI-assisted diagnostic imaging or interpretation system that requires human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This entire submission describes the standalone performance of the ARCHITECT i Vancomycin assay (an automated immunoassay system). There is no "human-in-the-loop" component in the direct measurement and quantitation of vancomycin levels. The device itself performs the assay and provides a quantitative result.
7. The Type of Ground Truth Used
The ground truth for the performance studies was established using:
- Known concentrations: For precision, recovery, linearity, sensitivity, and specificity studies, samples were prepared with precisely known concentrations of vancomycin or potential interfering/cross-reacting substances.
- Predicate device results: For the method comparison study, the results from the legally marketed predicate ARCHITECT i Vancomycin assay (LN 1P30-25) were used as the comparative "ground truth" to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device that requires a "training set" in the conventional sense. The device is a traditional immunoassay system with established chemical and optical principles.
However, if "training set" refers to the samples used during the development and optimization phases of the assay before formal validation, that information is not provided in this 510(k) summary. The provided details pertain to the formal validation studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm described in this submission. For the development and optimization of the immunoassay, ground truth would have been established through a combination of using known calibrators, controls, and potentially reference methods to ensure the assay's chemical and performance characteristics were appropriately tuned.
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(238 days)
The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma.
For in vitro diagnostic use.
The ARCHITECT iVancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The antivancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (ARCHITECT iVancomycin vs. AxSYM Vancomycin II) |
|---|---|
| Substantial equivalence in terms of precision | Demonstrated substantial equivalence |
| Substantial equivalence in terms of linearity | Demonstrated substantial equivalence |
| Substantial equivalence in terms of interferences | Demonstrated substantial equivalence |
| High correlation for quantitative measurement of vancomycin | Correlation coefficient of 0.996 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the clinical performance comparison, nor does it specify the country of origin of the data or whether it was retrospective or prospective. It only states that a "Summary of Clinical Performance" demonstrated "substantially equivalent performance" with a correlation coefficient of 0.996.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in vitro diagnostic device for quantitative measurement of vancomycin in human serum or plasma. Ground truth is established by a reference method (the predicate device) or by the inherent accuracy of the chemical measurement itself, rather than by human expert consensus or clinical assessment.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
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 typically performed for imaging or diagnostic interpretation tasks where human readers are involved. For an in vitro diagnostic device like this, the comparison is between the new device and a predicate device in terms of analytical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance assessment of the ARCHITECT iVancomycin assay. The device itself performs the quantitative measurement without human interpretation as part of its core function, although human operators are involved in running the assay. The comparison directly evaluates the device's analytical output against that of a predicate device.
7. The Type of Ground Truth Used
The ground truth or reference standard for evaluating the ARCHITECT iVancomycin assay's performance was the AxSYM Vancomycin II assay, which is the legally marketed predicate device. The clinical performance summary indicates a direct comparison of results between the new device and the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is an immunoassay, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a system involves the development and optimization of the reagent formulations, reaction conditions, and calibration procedures, which are determined during the device development phase, not through a "training set" of patient data as in machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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