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510(k) Data Aggregation
(36 days)
The PBNP assay used on the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic assay for the quantitative determination of Nterminal pro-brain natriuretic peptide (NT-proBNP) in human serum or plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
The PBNP method is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with monoclonal antibodies, which recognize an epitope located in the N-terminal part of proBNP, and a conjugate reagent [alkaline phosphatase (ALP)} labeled monoclonal 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 (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 NTproBNP present in the patient sample.
The provided text describes a 510(k) summary for the Dade Behring Dimension® PBNP reagent cartridge, which is an in vitro diagnostic assay. The document aims to demonstrate substantial equivalence to a predicate device (K041417/K042347).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but rather presents a comparison of performance characteristics between the new device and the predicate device, implying that meeting these characteristics substantially equivalent to the predicate is the "acceptance criterion" for regulatory approval.
| Feature / Performance Characteristic | Predicate Device (K041417/K042347) Reported Performance | New Device (Dimension® PBNP-mono) Reported Performance |
|---|---|---|
| Intended Use | Aid in diagnosis & assessment of CHF severity; risk stratification for ACS & heart failure, using human plasma. | Aid in diagnosis & assessment of CHF severity; risk stratification for ACS & heart failure, using human serum or plasma. |
| Assay Type (detection) | Immunoassay (chemiluminescent) | Immunoassay (chemiluminescent) |
| Reportable Range | 10 - 30,000 pg/mL | 10 - 30,000 pg/mL |
| Antibody | Polyclonal (sheep) antibody | Monoclonal (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 | ≤ 10 pg/mL | ≤ 10 pg/mL |
| Functional Sensitivity | ≤ 30 pg/mL | ≤ 30 pg/mL |
| Analytical Specificity | Natrecor® no significant cross-reactivity (0 or 125 pg/mL NT-proBNP); sixteen other substances no significant cross-reactivity. | Natrecor® no significant cross-reactivity (0 or 125 pg/mL NT-proBNP); sixteen other substances no significant cross-reactivity. |
| Interferences | No significant interference from: Bilirubin, conj. up to 60 mg/dL; bilirubin, 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. | No significant interference from: Bilirubin, conj. up to 60 mg/dL; bilirubin, unconj. up to 60 mg/dL; hemoglobin up to 1000 mg/dL; triglycerides up to 3000 mg/dL; rheumatoid factors up to 500 IU/mL. |
| 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 | 50 uL | 50 uL |
Study to Prove Device Meets Acceptance Criteria:
The document states: "Comparative data for human samples demonstrate good analytical and clinical agreement between the methods." This sentence refers to the study proving the new device meets the implied acceptance criteria (i.e., being substantially equivalent to the predicate).
However, the details of this study are very limited in the provided text.
Additional Information Not Available in the Text:
The provided text does not include information for the following points:
- Sample size used for the test set and the data provenance: Not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, and "experts" are not mentioned in the context of ground truth establishment for patient samples. Instead, the ground truth would be the measurement obtained from the predicate device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned, as this is a medical device for quantitative determination in a lab setting, not an imaging device requiring expert consensus for interpretation.
- 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 a lab-based immunoassay, not an AI-assisted diagnostic tool for human review.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a standalone in vitro diagnostic (immunoassay) that provides quantitative results. The performance comparison mentioned is likely between the new immunoassay and the predicate immunoassay, both operating without human interpretation in the results generation process itself.
- The type of ground truth used: For the comparative data, the predicate device's measurements likely served as the reference ("ground truth") to establish analytical and clinical agreement.
- The sample size for the training set: Not applicable, as this is an immunoassay, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
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