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510(k) Data Aggregation
(81 days)
The Dimension® PBNP Flex® method is an in vitro diagnostic assay for the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human plasma. Measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity of individuals suspected of having congestive heart failure and for risk stratification of patients with acute coronary syndrome and heart failure.
The Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The PBNP method is a one step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with polyclonal antibodies which recognize epitopes located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)] labeled polyclonal antibody specific for a second independent epitope on NT-proBNP, to form a particle/NT-proBNP/conjugate sandwich. Unbound conjugate is removed by magnetic separation and washing. After separation and washing, the particle/NT-proBNP/conjugate sandwich is transferred to the cuvette where the sandwich-bound ALP triggers an amplification cascade * ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to produce FAD. FAD binds to apo D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase produces multiple molecules of hydrogen peroxide (H2O2). H2O2 in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510 nm. The color change measured is directly proportional to the concentration of proBNP present in the patient sample.
Acceptance Criteria and Device Performance Study for Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method
This document summarizes the acceptance criteria and the study demonstrating the Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method meets these criteria, based on the provided FDA 510(k) summary. The device's performance is demonstrated through a comparison to a legally marketed predicate device, the Roche Diagnostics Elecsys® proBNP immunoassay, to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Dade Behring Dimension® PBNP Flex® method are implicitly defined by demonstrating substantial equivalence to the predicate device, the Roche Diagnostics Elecsys® proBNP immunoassay, across various performance characteristics. The reported device performance is directly compared to the predicate's performance.
| Feature | Acceptance Criteria (Predicate Device Performance - Roche Elecsys® proBNP) | Reported Device Performance (Dade Behring Dimension® PBNP) |
|---|---|---|
| Intended Use | Quantitative determination of NT-proBNP in human serum and plasma as an aid in diagnosis of suspected CHF and risk stratification of ACS and CHF patients. | Quantitative determination of NT-proBNP in human plasma as an aid in diagnosis and severity assessment of suspected CHF and for risk stratification of ACS and CHF patients. |
| Assay Type (detection) | immunoassay (electrochemiluminescent) | immunoassay (photometric) |
| Reportable Range | 5 - 35,000 pg/mL | 5 - 30,000 pg/mL |
| Antibody | polyclonal (sheep) antibody | Roche Diagnostics' polyclonal (sheep) antibody |
| Cut-off | 125 pg/mL for < 75 years, 450 pg/mL for ≥ 75 years | 125 pg/mL for < 75 years, 450 pg/mL for ≥ 75 years |
| Analytical Sensitivity | 5 pg/mL | ≤ 10 pg/mL |
| Functional Sensitivity | < 50 pg/mL | ≤ 30 pg/mL |
| Analytical Specificity | Natercor® shows no significant cross-reactivity (300/3000 pg/mL NT-proBNP); 16 other substances show no significant cross-reactivity. | Natercor® shows no significant cross-reactivity (0/125 pg/mL NT-proBNP); 16 other substances show no significant cross-reactivity. |
| Interferences | No significant interference from: bilirubin up to 35 mg/dL, hemoglobin up to 1.4 g/dL, triglycerides up to 4000 mg/dL, rheumatoid factors up to 1500 IU/mL. | No significant interference from: bilirubin (conj. up to 60 mg/dL, unconj. up to 20 mg/dL), hemoglobin up to 1000 mg/dL, triglycerides up to 3000 mg/dL, rheumatoid factors up to 500 IU/mL. |
| Reference | Roche NT-proBNP antibody (1-76) | Roche NT-proBNP antibody (1-76) |
| Hook Effect | No effect up to 300,000 pg/mL | No effect up to 300,000 pg/mL |
| Calibration Interval | 30 days - same reagent lot | 30 days - same reagent lot |
| Sample Volume | 20 uL | 50 uL |
| Reproducibility (Within Run) | 1.8% - 2.7% CV across various concentrations | 1.2% - 2.2% CV across various concentrations |
| Reproducibility (Total) | 2.2% - 3.2% CV across various concentrations | 3.1% - 5.7% CV across various concentrations |
2. Sample Size for the Test Set and Data Provenance
The document states, "Comparative data for human plasma samples demonstrate good analytical and clinical agreement between the methods." However, the specific sample size used for the test set is not explicitly provided in the furnished text.
The data provenance is stated as "human plasma samples." Without further detail, it is impossible to determine the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
This information is not explicitly provided in the furnished text. This being an in vitro diagnostic (IVD) device for quantitative measurement, "ground truth" typically refers to established values from reference methods, calibrators, or clinically validated samples rather than expert consensus on image interpretation. The study appears to rely on the predicate device as a "gold standard" for comparison.
4. Adjudication Method
Adjudication methods (e.g., 2+1, 3+1) are not typically applicable or mentioned for IVD device studies focusing on quantitative measurements and analytical agreement. The study focuses on direct comparison of measurements between the investigational device and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostics where human interpretation plays a significant role. The Dade Behring Dimension® NT-proBNP (PBNP) Flex® reagent cartridge method is an automated in vitro diagnostic assay, where human "readers" are not directly involved in interpreting the result; rather, clinicians interpret the quantitative output in the context of a patient's condition. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply here.
6. Standalone Performance
Yes, a standalone performance assessment was conducted. The performance characteristics (e.g., reportable range, analytical sensitivity, functional sensitivity, reproducibility, interference) detailed in the comparison table are inherently measurements of the device's standalone performance. These are the characteristics of the algorithm/method itself as it processes samples to produce a quantitative result. The comparison to the predicate then serves to demonstrate that this standalone performance is substantially equivalent to a legally marketed device.
7. Type of Ground Truth Used
The "ground truth" for this study is effectively the results obtained from the predicate device (Roche Diagnostics Elecsys® proBNP immunoassay). The study's primary objective is to demonstrate substantial equivalence to this predicate, suggesting that the predicate's performance represents the acceptable "truth" or standard against which the new device is measured. This is supported by the statement: "Comparative data for human plasma samples demonstrate good analytical and clinical agreement between the methods."
8. Sample Size for the Training Set
The sample size for the training set is not explicitly provided in the furnished text. As this is an immunoassay, the "training set" would typically refer to samples used during the development and optimization of the assay's reagents, calibration curves, and analytical parameters. This is distinct from a "training set" in machine learning contexts.
9. How the Ground Truth for the Training Set was Established
The method for establishing "ground truth" for the training set is not explicitly detailed in the furnished text. During the development of an immunoassay, the "ground truth" for training (i.e., assay optimization and calibration) would generally involve:
- Reference standards: Using highly purified and well-characterized NT-proBNP material to create calibrators with known concentrations.
- Spiked samples: Adding known concentrations of NT-proBNP to biological matrices to assess recovery and linearity.
- Comparison to existing methods: Utilizing established and validated methods (potentially the predicate itself or other reference methods) on a set of samples to refine the new assay's performance.
Given that the device "utilizes the Roche polyclonal (sheep) antibody/antigen set," it is likely that the development and "training" process leveraged existing knowledge and materials associated with the predicate's core components.
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