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510(k) Data Aggregation
(200 days)
ST AIA-PACK BNP Assay
The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human (K2EDTA) plasma on Tosoh AIA System Analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.
The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.
The Tosoh ST AIA-PACK BNP Assay aims to extend its measuring interval beyond 2,000 pg/mL through manual and automated 1:5 and 1:10 dilutions. This is a special 510(k) submission, meaning it refers to a device that has already been cleared (K192380) and modifications were made to it that do not significantly alter its performance or safety (e.g., modified firmware, revised labeling, minor material changes, etc.). Since this is a Special 510(k) and not a de novo submission, this document is a justification for substantial equivalence to its predicate device (K192380), and does not contain detailed information for how the predicate device was evaluated.
Therefore, the study summary below only refers to the performance of the modified device compared to its predicate device, and not a full evaluation of the predicate device's performance.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Manual Dilution | |
| Recovery value | 102% for 1:5 dilution |
| Recovery value | 100% for 1:10 dilution |
| On-board (automated) Dilution | |
| Recovery value | 95% for 1:5 dilution |
| Recovery value | 95% for 1:10 dilution |
2. Sample size used for the test set and data provenance
The document does not specify the sample sizes used for the manual and automated dilution studies, nor does it specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth method does not involve human experts; it relies on direct measurement.
4. Adjudication method for the test set
Not applicable. The ground truth method does not involve human experts.
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 versus without AI assistance
Not applicable. This is not an AI-assisted diagnostic device, but an in vitro diagnostic assay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an in vitro diagnostic assay, not an algorithm.
7. The type of ground truth used
The ground truth used for both manual and automated dilution studies is the recovery value of the BNP concentration after dilution, indicating the accuracy of the dilution process. This is a direct measurement based on the expected concentration after dilution.
8. The sample size for the training set
Not applicable. This device is an in vitro diagnostic assay and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This device is an in vitro diagnostic assay and does not involve machine learning or a training set.
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(360 days)
ST AIA-PACK BNP
The Tosoh ST AIA-PACK BNP assay is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of BNP in human K2EDTA plasma on Tosoh AIA System analyzers. BNP is used as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset HF, acutely decompensated or exacerbated HF.
The ST AIA-PACK BNP is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK BNP test cups. BNP present in the test sample is bound with monoclonal antibody immobilized on magnetic beads and enzyme-labeled monoclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the BNP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using the curve.
The provided text describes the performance characteristics and clinical study results for the ST AIA-PACK BNP assay, an in vitro diagnostic device. This device is intended for the quantitative measurement of BNP in human K2EDTA plasma as an aid in the diagnosis of heart failure (HF).
Here's an analysis of the acceptance criteria and the study proving the device meets these criteria, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format with pass/fail thresholds. Instead, it presents performance data from various analytical and clinical studies. We can infer performance parameters that would typically be subject to acceptance criteria in such a submission.
| Performance Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Precision | CV% within acceptable range across various concentrations and sources of variation | Combined Lots (n=240): |
| K2EDTA Plasma-1 (mean 10.588 pg/mL): Total CV 10.8% | ||
| K2EDTA Plasma-2 (mean 49.873 pg/mL): Total CV 3.6% | ||
| K2EDTA Plasma-3 (mean 106.718 pg/mL): Total CV 3.0% | ||
| K2EDTA Plasma-4 (mean 519.429 pg/mL): Total CV 5.1% | ||
| K2EDTA Plasma-5 (mean 1050.712 pg/mL): Total CV 6.1% | ||
| (Detailed SD and CV% for within run, between run, between day, between lot are provided for each of 3 lots and combined data, generally showing good precision.) | ||
| Linearity/Reportable Range | Assay demonstrated to be linear over the stated range | Linear from 4.0 to 2000 pg/mL |
| Detection Limit (LoD) | LoD within acceptable clinical range | LoD = 1.9 pg/mL |
| Quantitation Limit (LoQ) | LoQ within acceptable clinical range | LoQ = 3.5 pg/mL |
| Analytical Specificity (Interference) | Interference due to common substances and cross-reactants |
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