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510(k) Data Aggregation
(83 days)
For in vitro diagnostic use in the quantitative determination of Btype Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of heart failure. This assay is not intended for use on any other system.
The ADVIA® Centaur® BNP assay is a fully automated two-site sandwich immunoassay using direct chemiluminescent technology, which uses constant amounts of two monoclonal antibodies. The first antibody, in the Lite Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP F(ab')> fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Patient sample (calibrator or control materials) is incubated for 5 minutes at 37°C with the Lite Reagent that contains the tracer antibody conjugate. Subsequently, Solid Phase reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the BNP in the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. The chemiluminescence of the immuno-complex signal is measured in a luminometer. Samples with low BNP levels will have a minimum amount of bound AE label, while samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the amount of relative light units (RLUs) detected by the system.
The Bayer Diagnostics ADVIA Centaur BNP Assay is an in vitro immunoassay designed for the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma, to be used as an aid in the diagnosis of heart failure.
1. A table of acceptance criteria and the reported device performance
The provided text describes comparative performance against a predicate device and clinical agreement, rather than explicit pre-defined acceptance criteria with pass/fail thresholds. However, based on the comparative effectiveness study, we can infer the desired performance characteristics.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (ADVIA Centaur® BNP Immunoassay) |
|---|---|---|
| Analytical Agreement | High agreement with predicate device (Biosite Triage® BNP Test) at the 100 pg/mL decision threshold. | 94.7% (177/187) with a 95% Confidence Interval of 90.4% to 97.4%. |
| Clinical Agreement | High overall agreement with clinical diagnosis (HF vs. non-HF) at the 100 pg/mL decision threshold. | 87.2% (163/187) with a 95% Confidence Interval of 81.5% to 91.6%. The predicate device showed 86.1% clinical agreement. |
| Sensitivity | High sensitivity for detecting heart failure at the 100 pg/mL decision threshold. | 87.4% (146/167) with a 95% Confidence Interval of 81.4% to 92.0%. This is identical to the predicate device's sensitivity. |
| Specificity | Good specificity for not misidentifying non-heart failure patients as heart failure at the 100 pg/mL decision threshold. | 85.0% (17/20) with a 95% Confidence Interval of 62.1% to 96.8%. This is higher than the predicate device's specificity of 75.0%. |
| Precision | Comparable or better precision than the predicate device. | Within-run: 1.8 - 4.3 %CV from 29.4 - 1736.0 pg/mL. Total: 2.3 - 4.7 %CV from 29.4 - 1736.0 pg/mL. (Predicate: Average within-day 9.4 - 15.2 %CV; Average total 10.1 - 16.2 %CV). The ADVIA Centaur shows significantly better precision. |
| Analytical Sensitivity | Low detection limit. | <2 pg/mL (Predicate: 5 pg/mL). The ADVIA Centaur has a lower detection limit. |
| Measuring Range | Broad measuring range to cover clinically relevant levels. | <2.0 - 5000 pg/mL (Predicate: 5 - 5000 pg/mL). The ADVIA Centaur covers a similar range with a lower minimum detection. |
| Interference | No significant interference from common substances/drugs. | For the ADVIA Centaur, no interference was observed from: hemoglobin up to 1000 mg/dL, triglycerides up to 800 mg/dL, cholesterol up to 1000 mg/dL, urea up to 200 mg/dL, creatinine up to 2.5 mg/dL, unconjugated bilirubin up to 25 mg/dL, conjugated bilirubin up to 25 mg/dL, human IgG up to 5.3 g/dL, and 55 commonly used pharmaceutical drugs. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 187 patients. This includes 167 patients with heart failure (HF; clinical diagnoses of Class I – IV) and 20 individuals without heart failure (non-HF).
- Data Provenance: Not explicitly stated whether the data was retrospective or prospective, nor the country of origin. It was collected from "2 clinical trial sites."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The ground truth for the test set was clinical diagnoses of heart failure ("clinical diagnoses of Class I – IV"). The number and qualifications of experts involved in establishing these clinical diagnoses are not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The text does not mention any specific adjudication method for establishing the clinical diagnoses (ground truth). It simply refers to "clinical diagnoses."
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this study represents the standalone performance of the ADVIA Centaur BNP assay. It is an automated immunoassay where the algorithm (the assay and instrument system) determines the BNP levels without human interpretation of raw data beyond operating the instrument and collecting the results. The "performance characteristics" and "analytical/clinical agreement" tables directly reflect the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for evaluating clinical agreement was clinical status (clinical diagnosis of heart failure vs. non-heart failure). For analytical comparison, the ground truth was the results from the predicate device.
8. The sample size for the training set
The text does not provide information about a separate training set or its sample size. This document describes the performance evaluation of a device, not the development or training of a machine learning model.
9. How the ground truth for the training set was established
As there is no mention of a training set, the method for establishing its ground truth is not applicable/not provided.
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