(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 |
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”